Brain Disease Site

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CE8 (EORTC-1709-BTG)A Phase III Trial of Marizomib in Combination with Standard Temozolomide-Based Radiochemotherapy versus Standard Temozolomide-Based Radiochemotherapy Alone in Patients with Newly-Diagnosed Glioblastoma
This study aims to compare the overall survival of patients receiving standard treatment (Temozolomide-based radiochemotherapy followed by adjuvant temozolomide) for newly diagnosed Glioblastoma to those receiveing marizomib in combination with standard treatment. This comparision will be made across the entire patient population as well as the unmethylated MGMT subpopulation. This study will also examine patient neurocognitive function, quality of life and the saftey of marizomib combined with standard treatement.

Complexity Level: 2

Eligibility: WHO grade IV glioblastoma - Tumor resection or biopsy only - Availability of FFPR tumour block or slide for mandatory MGMT analysis - eligible for standard TMZ/RT ->TMZ - KPS>=70 - Recovered from effects of surgery - 18 years of age when ICF signed - stable or decreasing dose of steroids for 1 week prior - life expectancy of 3 months - Adequate organ function as per lab values - negative serum pregnancy test 7 days prior to first dose - no IDH1 mutation - no prior treatment for GBM other than surgery - planned treatment with TTF

Objectives: To compare the overall survival of glioblastoma patients treated with standard TMZ?-based radiochemotherapy alone or TMZ?-based radiochemotherapy in combination with marizomib. Additonally, PFS survival will be compared in the two treatment arms. Additionally the saftey and tolerability of TMZ?-based radiochemotherapy in combination with marizomib will be assesed. The neurocognitive function and OoL of the MRZ arm will also be assesed.

NCT Registration ID (from clinicaltrials.gov): NCT03345095
Participation: Limited to invited centres; Site Selection Open
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Open to Accrual
Activation Date: May 24, 2018

Chair: (Canada) Dr. Warren Mason, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2277


Open to Accrual
CEC6 (ALLIANCE N0577)Phase III Intergroup Study of Radiotherapy with Concomitant and Adjuvant Temozolomide versus Radiotherapy with Adjuvant PCV Chemotherapy in Patients with 1p/19q Co-deleted Anaplastic Glioma or Low Grade Glioma
The purpose of this study is to compare the effectiveness of 1) radiotherapy followed by PCV chemotherapy to 2)radiotherapy with temozolomide chemotherapy followed by additional temozolomide chemotherapy in the treatment of anaplastic glioma and low grade glioma, which are types of brain tumours. In this study, the patient's tumour cells are missing parts of chromosomes 1 and 19. Chromosomes are components of cells in the body which contain genetic information. These chromosomes are missing parts only in the tumour cells and are not typically missing in normal body cells. Tumours with this 1p/19q co-deletion typically have a more favorable outcome than other types of anaplastic glioma or low grade glioma.

Complexity Level: 2

Eligibility: Pre-registration - Inclusion Criteria Willing to submit tissue samples for mandatory central pathology review submission and deletion status determination. Registration Inclusion Criteria >18 years of age; Newly diagnosed and <3 months from surgical diagnosis; Histological confirmation of anaplastic glioma (oligodendroglioma, mixed, or astrocytoma [WHO grade 2 or 3]) or low grade glioma (WHO grade 2), as determined by pre-registration central pathology review, and tumor is co-deleted for 1p and 19q. NOTE: Mixed gliomas are eligible. Patients with codeleted low grade gliomas must also be considered "high risk." Tumor tissue must show co-deletion of chromosomes 1p and 19q by FISH analysis. Surgery must be performed >2 weeks prior to registration. Patient must have recovered from the effects of surgery; The following laboratory values obtained <21 days prior to registration: ANC>1500/mm^3; PLT>100,000/mm^3; Hgb>9 g/dL; Total bilirubin<1.5 x UNL; SGOT (AST)<3 x UNL; Creatinine<1.5 x ULN

Objectives: To determine whether patients who receive radiotherapy with concomitant temozolomide followed by adjuvant temozolomide have a marginally better progression free survival as compared with patients who receive radiotherapy followed by PCV.

NCT Registration ID (from clinicaltrials.gov): NCT00887146
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Open to Accrual
Activation Date: March 22, 2016

Chair: (Canada) Dr. J. Gregory Cairncross, Foothills Medical Centre, (403) 944-1260


Open to Accrual
CE7 (CCTG CE.7)A Phase III Trial of Stereotactic Radiosurgery compared with Whole Brain Radiotherapy (WBRT) for 5-15 Brain Metastases
Testing stereotactic radiosurgery, a type of targeted radiation therapy, versus whole brain radiotherapy in people with cancer that has spread to the brain.

Complexity Level: 2

Eligibility: - Patient must have 5 or more brain metastases by MRI obtained within 30 days of registration. Largest brain metastasis must be <2.5cm, and total tumour volume must be 30cm3 or less - Patient must be willing and able to complete QoL questionnaires, neurocognitive assessments, and must agree to use effective contraception if of child bearing potential - Centre must be IROC credentialied and able to treat patients using an SRS system - Patient must have a pathological diagnosis of a non-hematopoietic malignancy - Patient must be >18 years old, ECOG 0-2, and creatinine clearance of 30ml/min or more

Objectives: Primary Endpoints: - Overall Survival and neurocognitive PFS Secondary Endpoints: - time to CNS failure; difference in CNS failure patterns;number of salvage procedures following SRS; cognitive tests; adverse events; time delay to re-initiation of systemic therapy post treatment; validate nomogram; Health Economics; Quality of Life; Correlative Studies; Imaging data collection and evaluation

NCT Registration ID (from clinicaltrials.gov): NCT03550391
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: On Hold
Activation Date: May 25, 2018

Chair: (Canada) Dr. David Roberge, CHUM-Centre Hospitalier de l'Universite de Montreal, (514) 890-8254, (USA) Dr. Michael Chan, Wake Forest School of Medicine, (336) 713-3600


On Hold
CE5 (EORTC 22033-26033)Primary Chemotherapy with Temozolomide vs. Radiotherapy in Patients With Low Grade Gliomas After Stratification for Genetic 1p Loss: A Phase III Study.
The purpose of this study is to compare the effects on you and your low-grade glioma of a new drug temozolomide to radiotherapy treatment which is usually used to treat this disease. This research is being done because we do not know which of these two treatments is better for low-grade glioma.

Complexity Level: 2

Eligibility: At registration: -Histologically proven low grade diffuse glioma (Astrocytoma WHO grade II , gemistocytic, fibrillary and protoplasmatic), Oligoastrocytoma WHO grade II and oligodendroglioma WHO II); supratentorial location only -WHO performance status <2; Age > 18 years; Informed consent; At randomization : Same as above +; Requiring treatment as demonstrated by at least one of the following criteria (1-4): 1. Age >40 years; 2. Radiologically proven progressive lesion; 3. Neurological symptoms others than seizures only (focal deficits, signs of raised intracranial pressure, mental deficits); 4. Intractable seizures; Not candidate for treatment exclusively by surgery; RTOG neurological function 0-3; Results of genetic testing (1p) available; Adequate hematological, renal and hepatic function; No previous radiotherapy to the brain, no prior chemotherapy, patient EORTC 22033-26033 RTX vs. TMZ in LGG stratifying for 1p loss; has recovered from any surgery; No second primary exc BCC skin

Objectives: Primary: PFS Secondary: Overall survival, Quality of life and Minimental State Examination (MMSE), Adverse events, neurocognitive function (for dedicated centers)

NCT Registration ID (from clinicaltrials.gov): NCT00182819
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: January 06, 2006 Closing Date: March 28, 2013

Chair: (Canada) Dr. Warren Mason, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2277


Closed to Accrual
CE5S (NCIC CTG)Socio-behavioral Study Work, Marriage/Social Support, Anxiety and Depression NCIC CTG CE5S
We are hoping to see how coping with a brain tumour and its treatment impacts your mood, social support, work and financial status. We are particularly interested in seeing how things might change throughout your treatments and in survivorship.

Complexity Level: 3

Eligibility: Histologically proven low-grade glioma. Astrocytoma WHO grade II, Obligoastrocytoma WHO grade II, Oligodendroglioma WHO grade II, Supratentorial tumor location only, WHO performance status < or =2, Age > or =18, no previous chemo/rad for brain tumour.

Objectives: The goal of this supplemental evaluation is to add a socio-behavorial component to the CE5 protocol in order to provide a more detailed description of important social (marital status), emotional (depression, anxiety) and occupational (work status) consequences of low grade glioma and its treatments.

Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Closed to Accrual
Activation Date: January 22, 2007 Closing Date: April 11, 2013

Chair: (Canada) Dr. Anne Leis, University of Saskatchewan, (306) 966-7878, (Canada) Ms. Maureen Parkinson, BCCA - Vancouver Cancer Centre


Closed to Accrual
CEC1 (RTOG 0834)Phase III Trial On Concurrent And Adjuvant Temozolomide Chemotherapy In Non-1p/19q Deleted Anaplastic Glioma. The CATNON Intergroup Trial.
This study investigates the addition of chemotherapy with temozolomide to radiotherapy. Patients recently operated upon for a primary brain tumor, called an anaplastic glioma (or more specifically, an anaplastic astrocytoma, an anaplastic oligoastrocytoma or an anaplastic oligodendroglioma). The doctor will plan further treatment for the patient, which may consist of radiotherapy, chemotherapy or a combination of both.

Complexity Level: 2

Eligibility: Histologically confirmed newly diagnosed anaplastic oligodendroglioma, anaplastic oligoastrocytoma or anaplastic astrocytoma by local diagnosis

Objectives: To assess whether concurrent radiotherapy with daily temozolomide chemotherapy improves overall survival as compared to no daily temozolomide in patients with non-1p/19q deleted anaplastic glioma. To assess whether adjuvant temozolomide chemotherapy improves survival as compared to no adjuvant temozolomide chemotherapy in patients with non-1p/19q deleted anaplastic glioma.

NCT Registration ID (from clinicaltrials.gov): NCT00626990
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: July 22, 2009 Closing Date: September 15, 2015

Chair: (Canada) Dr. Warren Mason, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2277


Closed to Accrual
CEC2 (NCCTG N0577)Phase III Intergroup Study of Radiotherapy versus Temozolomide Alone versus Radiotherapy with Concomitant and Adjuvant Temozolomide for Patients with 1p/19q Codeleted Anaplastic Glioma
The two main reasons this research study is being done are to see if: " people have longer survival if they get treatment with the combination of both radiation therapy and temozolomide chemotherapy as compared to people who receive treatment with radiation therapy alone. " people treated with temozolomide therapy alone (no radiation therapy) have a better or worse quality of life and mental function than those patients who are treated with either the combination of radiation therapy and temozolomide or radiation therapy alone. Survival will also be monitored in the people getting temozolomide alone.

Complexity Level: 2

Eligibility: Pre-registration . Inclusion Criteria - Willing to submit tissue samples for mandatory central pathology review submission and deletion status determination. It should be initiated as soon after surgery as possible. Inclusion Criteria >18 years of age; Newly diagnosed and .3 months from surgical diagnosis; Histological confirmation of anaplastic glioma (oligodendroglioma, mixed, or astrocytoma [WHO grade III]), as determined by pre-registration central pathology review, and tumor is also co-deleted for 1p and 19q. NOTE: Mixed gliomas are eligible, regardless of the degree of astrocytic or oligodendrocytic predominance, as long as the tumor is also co-deleted for 1p and 19q; 3.24 Surgery .2 weeks prior to registration must have recovered from the effects of surgery; The following laboratory values obtained 21 days prior to registration. . ANC .1500; . PLT .100,000; . Hgb>9; Total bilirubin .1.5 x UNL; SGOT (AST) .3 x UNL; Creatinine .1.5 x ULN

Objectives: Survival; Progression Free Survival; Quality of Life; Cognitive Function; Correlative Biology.

NCT Registration ID (from clinicaltrials.gov): NCT00887146
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: July 28, 2010 Closing Date: January 14, 2015

Chair: (Canada) Dr. J. Gregory Cairncross, Foothills Medical Centre, (403) 944-1260


Closed to Accrual
CEC3 (NCCTG N107C)A Phase III Trial of Post-Surgical Stereotactic Radiosurgery (SRS) Compared with Whole Brain Radiotherapy (WBRT) for Resected Metastatic Brain Disease


Complexity Level: 1

Eligibility: Four or fewer brain metastases (as defined on the pre-operative MRI brain scan) and status post resection of one of the lesions. Pathology from the resected brain metastasis must be consistent with a non-central nervous system primary site.

Objectives: Primary: Overall Survival, Cognitive Function Secondary: Local Control Of The Surgical Bed; Time To CNS Failure; Various Quality Of Life; A Biologic Correlate

NCT Registration ID (from clinicaltrials.gov): NCT01372774
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: September 29, 2011 Closing Date: December 18, 2015

Chair: (Canada) Dr. David Roberge, CHUM-Centre Hospitalier de l'Universite de Montreal, (514) 890-8254


Closed to Accrual
CEC5 (ALLIANCE A221208)Phase II Study of Corticosteroid + Bevacizumab vs Corticosteroid + Placebo (BeST) for Radionecrosis after Radiosurgery for Brain Metastases
This investigation compares the effects of bevacizumab plus standard corticosteroid therapy to placebo plus standard corticosteroid therapy on brain radionecrosis in patients who received radiosurgery for brain cancer. Brain radionecrosis is a non-cancerous condition that makes up an area of dead tissue in the brain that is surrounded by inflamed (swollen) tissue. This condition can happen after a patient receives intense radiation therapy for brain cancer, such as if they have radiosurgery. The standard corticosteroid treatment only works for some patients and can cause significant side effects. The purpose of this study is to test whether adding bevacizumab to the standard corticosteroid therapy will improve the symptoms over corticosteroid therapy alone by improving the radionecrosis and minimizing treatment-related side effects.

Complexity Level: 2

Eligibility: Patients enrolled in this study must have a diagnosis of radionecrosis based on a clinical onset of symptoms and radiological findings of radionecrosis at 3 - 24 months following radiosurgery for brain metastases, with or without pathological confirmation. For this trial, the primary solid tumour indicating brain metastases includes, but is not limited to: lung, breast, colorectal cancer, but excluding melanoma, choriocarcinoma, renal cell carcinoma or gliomas (due to high risk of intratumoural hemorrhage). Prior to the start of treatment patient must have been taking a stable dose of corticosteroids for symptom management for at least 1 week before baseline MRI. Patients will have a Karnofsky Performance Status > 60%. It is required that patients do not have any systemic therapy within 2 weeks prior to registration or plan for systemic therapy within the first 8 weeks after study registration (with exceptions) nor any bevacizumab within 3 months of study registration.

Objectives: Primary Objective:To investigate whether the addition of bevacizumab to standard corticosteroid therapy results in greater improvement in symptoms (clinical and patient-reported symptom improvement associated with radionecrosis and less radionecrosis treatment-induced symptoms) compared with standard corticosteroid therapy. Secondary Objectives:To evaluate the toxicity profile associated with bevacizumab and corticosteroid therapy.To compare self-reported health related quality of life (HRQOL) using LASA, Dexamethasone Symptoms Questionnaire-Chronic (DSQ-C), and MDASI-BT symptom and interference score between treatment arms.To compare intracranial progression-free survival and time to maximum radiographic response between treatment arms.To compare the dose and duration of corticosteroid required between treatment arms and correlate steroid requirement with DSQ-C and MDASI-BT scores.Correlative Objectives:To explore serum/urine/imaging biomarkers that predict for treatment response.

NCT Registration ID (from clinicaltrials.gov): NCT02490878
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: December 23, 2016 Closing Date: October 12, 2018

Chair: (USA) Dr. Caroline Chung, M.D. Anderson Cancer Center, (Canada) Dr. Warren Mason, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2277


Closed to Accrual
I222A Phase I Study of the mTORC1/mTORC2 Kinase Inhibitor AZD2014 in Patients with Previously Treated Glioblastoma Multiforme
The main purpose of this study is to determine the recommended phase II dose and safety profile of AZD2014 combined with standard temzolomide in patients with previously treated glioblastoma multiforme, and to estimate the 6 month progression-free rate and response in patients receiving AZD2014 in addition to their standard temozolomide treatment for the phase 2 portion. Secondary, to explore potential biomarkers such as PTEN, PI3KCA and other mutations, as well as evidence of pharmacodynamic effects in resected and archival tumour tissue.

Complexity Level: 1

Eligibility: Histologically confirmed glioblastoma multiforme that is recurrent after primary treatment, phase II must have measurable disease according to RANO criteria. ECOG 0-1. Radiation completed >= 4 weeks prior registration; surgery within 21 days (excluding resection). No clinically significant cardiac disease in last 12 months such as (coronary artery bypass graft, angioplasty, vascular stent, MI, congestive heart failure NYHA Grade 2, ventricular arrhythmias requiring continuous therapy, uncontrolled arrhythmias including atrial fibrillation, hemorrhagic or thrombotic stroke). No hepatitis B, hepatitis C, HIV or a prior history of tuberculosis, or diabetes type I or uncontrolled type II. No interstitial lung disease. No GI disease, meningeal or extracranial GBM involvement. No known QT/QTc-prolonging drugs. Stable or decreasing dose of corticosteroids. No enzyme inducing anticonvulsants. No medications that are metabolized by CYP3A4/5 5 and CYP2C8, Pgp (MDR1) and BCRP

Objectives: Primary:To determine the recommended phase II dose (RP2D) of AZD2014 in patients receiving standard temozolomide treatment. To estimate the 6 month PFS rate in patients receiving AZD2014 in addition to their standard temozolomide treatment Secondary:To evaluate the plasma levels of AZD2014 alone at the time of resection. To assess the safety and toxicity profile of AZD2014 in patients receiving standard temozolomide treatment. To evaluate potential biomarkers such as PTEN, PI3KCA and other mutations, as well as evidence of pharmacodynamic effects in resected and archival tumour tissue.

NCT Registration ID (from clinicaltrials.gov): NCT02619864
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Closed to Accrual
Activation Date: January 13, 2016 Closing Date: October 19, 2018

Chair: (Canada) Dr. Warren Mason, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2277


Closed to Accrual
CE1NCIC Cooperative Clinical Trial on Treatment of Cerebral Tumours (Glioblastomas) With Pre-Operative BCNU and Superfractionated Radiotherapy


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: May 05, 1980 Closing Date: December 15, 1981

Permanently Closed
CE2 (RTOG 94-02)Phase III Intergroup Randomized Comparison of Radiation Alone versus Pre-radiation Chemotherapy For Pure and Mixed Anaplastic Oligodendrogliomas.
The purpose of the study is to find out the best way to use chemotherapy in the treatment of oligodendrogliomas. Should chemotherapy be given at an early stage together with radiotherapy, or only given if the tumor regrows after radiation? To do this, half of the patients in the study will get chemotherapy (PCV) and radiation after diagnosis and the other half will receive radiation alone but PCV may be given late if the radiation fails.

Complexity Level: 2

Eligibility: Patients with histologically confirmed supratentorial pure or mixed anaplastic oligodendrogliomas who have not received prior radiotherapy or chemotherapy and do not have chronic lung disease; a Karnofsky performance status of > 60 and adequate blood counts, liver and kidney function required.

Objectives: To compare overall survival and time to tumour progression in patients treated with intensive-PVC (procarbazine, CCNU [lomustine] and vincristine)followed by radiation to those patients treated with radiation alone. Also to compare the frequencies of severe toxicities, quality of life and neurologic function between the two arms.

NCT Registration ID (from clinicaltrials.gov): NCT00002569
Participation: Limited to centres 1) which are not currently RTOG members; 2) with current CPA #
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: October 23, 1996 Closing Date: March 29, 2002

Chair: (Canada) Dr. Normand J. Laperriere, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2127


Permanently Closed
CE3 (26981-22981)A Randomized Phase III Study of Concomitant and Adjuvant Temozolomide and Radiotherapy For Newly Diagnosed Glioblastoma Multiforme
The purpose of this study is to look at whether treatment with temozolomide during and after radiation therapy improves survival and quality of life in patients with a newly diagnosed GBM, compared to radiation therapy alone. Despite these treatments these tumors cannot be cured and they eventually recur. Therefore, new treatments are being investigated to treat patients with GBM.

Eligibility: Patients with histologically confirmed newly diagnosed glioblastoma multiforme who have not received prior chemotherapy or radiotherapy; 18 to 70 years of age; WHO performance status < 2; stable, non-increasing dose of corticosteroids; adequate blood counts, liver and kidney function.

Objectives: The primary objective of the trial is to test the efficacy of administration of temozolomide as a concomitant and adjuvant treatment to radiotherapy with respect to overall survival compared to radiotherapy alone. The secondary objectives are to compare the two treatment arms with respect to toxicity profile, progression free survival and quality of life.

NCT Registration ID (from clinicaltrials.gov): NCT00006353
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: May 29, 2000 Closing Date: March 22, 2002

Chair: (Canada) Dr. Barbara J. Fisher, London Regional Cancer Program, (519) 685-8650, (Switzerland) Dr. Roger Stupp, University Hospital CHUV, (21) 314-0156


Permanently Closed
CE4 (26021)Observation Versus Conventional-Fractionated Radiotherapy or Radiosurgery After Non-Radical Surgery for Benign Intracranial Meningiomas: a Phase III Study.
The purpose of this study is to find out whether adding irradiation after a benign intracranial meningioma has been removed with surgery will increase the likelihood of patients with remaining tumour having a longer time to recurrence compared to the current standard treatment of surgery alone. This research is being done because although the current standard treatment is surgical removal of the benign tumour, in some cases, the meningioma cannot be completely removed. The researchers would like to study whether irradiation is a better alternative to watchful observation after surgical removal of the tumour. This study will also compare the quality of life, overall survival and likelihood of a second surgery between patients who do not undergo any further treatment and patients who will receive irradiation.

NCT Registration ID (from clinicaltrials.gov): NCT00104936
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: September 29, 2005 Closing Date: October 23, 2006

Permanently Closed
CE6 (CE6)A Randomized Phase III Study of Temozolomide and Short-Course Radiation vs. Short-Course Radiation Alone in the Treatment of Newly Diagnosed Glioblastoma Multiforme in Elderly Patients.
Glioblastoma Multiforme (GBM) is a type of brain cancer treated with surgery and radiation therapy (RT). Temozolomide (TMZ) is a new drug. A previous clinical study in GBM patients up to 71 years of age showed that when TMZ is added to the usual (i.e. "long") course of RT it slows the growth of GBM and prolongs life compared to treatment with the long course of RT alone. However, the results of this trial suggested that the benefit from TMZ decreases with increasing age. Also, elderly patients are not usually able to tolerate the long RT course and are instead perscribed a shorter one. Thus, researchers do not know if TMZ is of benefit to elderly patients, neither do they know if its combination with the short course of RT will be as effective as with the long course of RT. CE.6 will attempt to answer these questions by enrolling GBM patients 65 yers or older who are not considered suitable for the long course RT. Patients will be randomized to short RT alone or to short RT plus TMZ.

Complexity Level: 2

Eligibility: Patients 65 years of age or older, with newly diagnosed, histopathologically confirmed, glioblastoma multiforme (GBM, WHO grade IV), who have had prior surgery/biopsy at diagnosis and who are not deemed suitable by their treating physician to receive the standard radiotherapy regimen (60Gy/30 fractions over 6 weeks) in combination with temozolomide.

Objectives: PRIMARY: To compare the overall survival (OS) rates between short-course radiation therapy alone and short-course radiation therapy given together with concurrent and adjuvant temozolomide, in elderly (65 years of age or older) patients with newly diagnosed glioblastoma multiforme (GBM, WHO grade IV), who have had prior surgery/biopsy at diagnosis and who are not deemed suitable by their treating physician to receive the standard radiotherapy regimen (60Gy/30 fractions over 6 weeks) in combination with temozolomide. SECONDARY: To compare progression-free survival (PFS) between the two arms; To compare the nature, severity, and frequency of adverse events between the two arms; To compare the quality of life between the two arms using the EORTC QLQ-C30 and the EORTC Brain Cancer Module (QLQ-BN20); To conduct molecular correlative studies (mandatory: MGMT promoter status; optional: tissue banking).

NCT Registration ID (from clinicaltrials.gov): NCT00482677
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: May 01, 2007 Closing Date: October 01, 2013

Chair: (Italy) Dr. Alba Brandes, Bellaria - Maggiore Hospital, (Australia) Dr. Claire Phillips, Trans-Tasman Radiation Oncology Group, (Belgium) Dr. Johan Menten, EORTC Data Center, (Canada) Dr. Normand J. Laperriere, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2127, (Australia) Dr. Mike Fay, Trans-Tasman Radiation Oncology Group, (Canada) Dr. James Perry, Odette Cancer Centre, (416) 480-5000 Ext. 4766


Permanently Closed
I109NCIC CTG Phase II Study of Topotecan in Patients With Anaplastic Oligodendroglioma or Anaplastic Mixed Oligoastrocytoma


NCT Registration ID (from clinicaltrials.gov): NCT00003372
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: December 08, 1997 Closing Date: April 20, 2000

Chair: (Canada) Dr. Karl Belanger, CHUM-Centre Hospitalier de l'Universite de Montreal, (514) 890-8000 Ext. 25381


Permanently Closed
I13NCIC CTG Phase II Study of N-methylformamide in Glioma


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: December 01, 1984 Closing Date: April 29, 1985

Permanently Closed
I139A Phase II Study of T138067-Sodium in Patients With Malignant Glioma


Eligibility: Histologically proven malignant glioma (glioblastoma multiforme or anaplastic astrocytoma). Recurrent or progressive disease following primary surgery and radiation treatment. Up to ONE prior chemotherapy regimen in the adjuvant setting, no chemotherapy for recurrence. Stable dose of steriod for > 14 days prior to registration.

Objectives: To determine the efficacy and toxicity of T138067-sodium in patients with recurrent malignant glioma when given as a weekly 3-hour infusion. To determine the pharmacokinetics of T138067-sodium in a subset of patients (6) enrolled on this study.

NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: November 08, 2000 Closing Date: January 09, 2002

Permanently Closed
I142A Phase II Study of SarNU (NSC 364432) in Patients With Malignant Glioma
The purpose of this study is to find out what effects the experimental drug SarCNU has on patients with malignant glioma. In addition, this study will evaluate the side effects of SarCNU. This research is being done because SarCNU has not been tested in brain tumours and it comes from a family of drugs which are known to be effective in some patients.

Eligibility: Patients with recurrent histologically proven malignant glioma (anaplastic astrocytoma or glioblastoma multiforme). Patients with anaplastic astrocytoma may have had up to ONE prior chemotherapy regimen in the adjuvant setting, but NO chemotherapy for recurrence. Patients with glioblastoma multiforme must be chemotherapy-naive. Bidimensionally measurable enhancing lesions on CT or MRI.

Objectives: To determine the efficacy of SarCNU given orally on days 1, 5 and 9 every 6 weeks in patients with recurrent malignant glioma. To determine time to progression, survival and qualitative and quantitative toxicity of SarCNU in this schedule in this patient population. Laboratory correlative studies will also be done.

NCT Registration ID (from clinicaltrials.gov): NCT00036660
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: January 10, 2002 Closing Date: December 17, 2002

Chair: (Canada) Dr. J. Gregory Cairncross, Foothills Medical Centre, (403) 944-1260


Permanently Closed
I162A Phase I Study Of Temozolomide And RAD001C In Patients With Malignant Glioma
The purpose of this study is to find the highest dose of the drug RAD001C that can be given with standard doses of temozolomide without causing very severe side effects that are not tolerable.

Eligibility: Patients with newly diagnosed (no prior chemotherapy permitted) or recurrent (only one prior adjuvant chemo regimen permitted), glioblastoma multiforme (GBM). Bidimensionally measurable disease. Stable dose of steroids. Paraffin embedded tumour sample available for study.

Objectives: To assess the toxicity, pharmacokinetics, efficacy, MTD, and RPII dose(s) of RAD001C when given in combination with standard dose of Temozolomide in patients with GBM. Patients receiving enzyme inducing anti-epileptic drugs (EIAEDs) and those not receiving EIAEDs will be studied separately.

NCT Registration ID (from clinicaltrials.gov): NCT00387400
Participation: Participation in this study is restricted to invited centres.
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: July 25, 2006 Closing Date: June 01, 2009

Chair: (Canada) Dr. Warren Mason, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2277


Permanently Closed
I170A Phase I/II Study of GW572016 in Patients With Recurrent Malignant Glioma


Eligibility: Patients with recurrent glioblastoma multiforme (GBM) following primary surgery and radiation. No prior chemotherapy for recurrent disease permitted. Bidimensionally measureable disease. Stable dose of steriods. Paraffin embedded tumour sample available for study.

Objectives: To determine the toxicity, MAD, and RPII dose of GW572016 when given in patients with GBM taking CYP3A4 enzyme inducing anti-epileptic drugs. To assess the efficacy of GW572016 when administered daily in appropriate recommended doses to patients with recurrent GBM.

NCT Registration ID (from clinicaltrials.gov): NCT00099060
Participation: Participation in this study is restricted to invited centres.
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: December 16, 2004 Closing Date: May 08, 2007

Chair: (Canada) Dr. Brian Thiessen, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2734


Permanently Closed
I204A Phase II Study of PX-866 in Patients with Glioblastoma Multiforme at Time of First Relapse or Progression.
The main purpose of this study is to find out how effective the experimental drug PX-866 is in treating glioblastoma multiforme. In addition, this study will look at the side effects of PX-866. Treatment with PX-866 will be once daily by mouth for an 8-week cycle. Researchers will also look at cancer cell markers from the patient's archival tissue sample.

Complexity Level: 2

Eligibility: Patients must have histologically confirmed diagnosis of glioblastoma multiforme (GBM), with recurrent or progressive disease following or during primary treatment not curable with standard therapies. Must have formalin fixed paraffin embedded tissue available for translational studies. Presence of bidimensionally measurable enhancing lesions on CT or MRI, with at least one lesion with a minimum dimension of 1 cm x 1 cm (i.e. both dimensions must be > 1.0 cm). ECOG performance of 0, 1 or 2.Age > 18 years of age. Patients may have received prior adjuvant chemotherapy and/or concurrent chemoradiation as part of primary therapy, but must have received no therapy for recurrent/ progressive GBM

Objectives: To determine the efficacy of PX-866 given orally daily in patients with glioblastoma at the time of first relapse or progression as assessed by objective response and early progression rates. To determine the safety and tolerability of PX-866 in patients with glioblastoma at first relapse/progression given in a daily oral schedule. To explore the relationship between objective response and molecular markers in archival tissue from glioblastoma patients treated with PX-866 orally daily.

NCT Registration ID (from clinicaltrials.gov): NCT01259869
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: December 09, 2010 Closing Date: September 24, 2012

Chair: (Canada) Dr. Marshall W. Pitz, CancerCare Manitoba, (204) 787-8642


Permanently Closed
I27NCIC CTG Phase II Study of Trimetrexate in Glioma


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: July 28, 1986 Closing Date: March 14, 1988

Permanently Closed
I48NCIC CTG Phase II Study of "Intensive PCV-3" Chemotherapy For Anaplastic Oligodendroglioma


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: February 06, 1989 Closing Date: September 02, 1992

Chair: (Canada) Dr. David R. MacDonald, London Regional Cancer Program, (519) 685-8640, (Canada) Dr. J. Gregory Cairncross, Foothills Medical Centre, (403) 944-1260


Permanently Closed
I54NCIC CTG Phase II Study of TCAR in Malignant Glioma


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 18, 1990 Closing Date: May 28, 1991

Permanently Closed
I75NCIC CTG Phase II Study of Topotecan in Patients With Malignant Glioma


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: September 08, 1992 Closing Date: January 25, 1994

Permanently Closed
I76NCIC CTG Phase II Study of Taxotere in Malignant Glioma


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 04, 1994 Closing Date: April 28, 1995

Permanently Closed
I94NCIC CTG Phase II Study of Gemcitabine in Patients With Malignant Glioma


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: May 06, 1996 Closing Date: April 28, 1997

Permanently Closed