Melanoma Disease Site

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ME15 (MELMART-II)Melanoma Margins Trial II - A Phase III, Multi-centre Randomized Controlled Trial Investigating 1cm vs 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanom (MelMarT-II)


Complexity Level: 2

Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Planned

Chair: (Canada) Dr. Frances C. Wright, Odette Cancer Centre, (416) 480-5000 Ext. 3835


Planned
I224A Phase II Study of Concurrent Dabrafenib and Trametinib with Stereotactic Radiation in the Management of Patients with BRAF Mutation-Positive Malignant Melanoma and Brain Metastases
The main purpose of the study is to find out the intracranial objective response rate to dabrafenib and trametinib with non-surgical radiation in patients with malignant melanoma and brain metastases. Dabrafenib will be taken twice a day and trametinib once a day. Patients will begin taking study drug a minimum of 7 days and a maximum of 14 days prior to starting non-surgical radiation.

Complexity Level: 2

Eligibility: Histologically confirmed melanoma metastatic to brain and determined to be BRAF V600 mutation-positive. Presence of measurable disease (with at least one measurable CNS lesion per RECIST 1.1). Presence of 1-10 brain metastases as confirmed on a thin slice axial T1 post-gadolinium MRI sequence. Maximum diameter of a single brain lesion should be <=4 cm. All CNS metastases amenable to single fraction SRS and/or fractionated SRS. ECOG 0-1. No prior treatment with a BRAF inhibitor or MEK inhibitor. No history of malignancy with confirmed activating RAS mutation at any time. No history of HEP B or HEP C virus and no history of interstitial lung disease or active pneumonitis. No prior whole brain radiation or brainstem metastases. No contraindications to MRI and/or Gadolinium contrast or stereotactic brain radiation therapy. No history or current evidence/risk of retinal vein occlusion or central serous retinopathy.

Objectives: Primary Objective: To determine intracranial objective response rate; Secondary objectives: extra-cranial objective response rate and overall ORR; duration of response; intracranial and overall progression free survival; overall survival and to evaluate the safety and tolerability of the regimen using CTCAE v. 4.

NCT Registration ID (from clinicaltrials.gov): NCT02974803
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: November 23, 2016

Chair: (Canada) Dr. Arjun Sahgal, Odette Cancer Centre, (416) 480-4834, (Canada) Dr. Teresa M. Petrella, Odette Cancer Centre, (416) 480-4662


Open to Accrual
ME13A Randomized Phase III Trial of the Duration of Anti-PD-1 Therapy in Metastatic Melanoma (STOP-GAP)
"PD-1 inhibitors" are new immunotherapeutic agents effective in prolonging survival in metastatic melanoma. Currently, patients are being offered continuous treatment with approved and publically-funded PD-1 inhibitors for 24 months. However, some data suggest that patients respond early and may respond again at treatment re-induction. Given that PD-1 inhibitors are expensive and may lead to serious immune-related adverse reactions, the optimal treatment duration for these agents is one of the key questions for clinicians, governments and patients. This trial hypothesizes that intermittent PD-1 inhibitor treatment, following maximum benefit on initial treatment, is no worse for survival compared to continuous treatment for 24 months. If confirmed, this strategy will be practice-changing and it is anticipated that it will result in less toxicities, better quality of life and decreased costs.

Complexity Level: 2

Eligibility: Patients with unresectable / metastatic (stage III or stage IV) melanoma, who are eligible to receive Health Canada approved, publically-funded PD-1 inhibitors.

Objectives: PRIMARY: To determine whether the Overall Survival (OS) of patients randomized to intermittent PD-1 inhibitor therapy is non-inferior to that of patients randomized to continuous PD-1 inhibitor therapy, in unresectable / metastatic (stage III or stage IV) melanoma. SECONDARY OBJECTIVES: (1) Progression-Free Survival, (2) Response rate and duration of response, (3) Adverse Events profile, (4) Quality of LIfe and (5) Economic Evaluation

NCT Registration ID (from clinicaltrials.gov): NCT02821013
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: July 04, 2016

Chair: (Canada) Dr. Tara Baetz, Cancer Centre of Southeastern Ontario at Kingston, (613) 549-6666 Ext. 6654, (Canada) Dr. Xinni Song, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 70208


Open to Accrual
I225A Phase II Study of the Assessment of Response to Pembrolizumab in Metastatic Melanoma: CT Texture Analysis as a Predictive Biomarker
The main purpose of this study is to find out if tumour CT texture analysis (enhancing of images in ultra-fine detail not visible to the human eye) can predict time to progression and response more accurately. Pembrolizumab will be given by needle Day 1 every three weeks.

Complexity Level: 2

Eligibility: Histologically confirmed melanoma that is recurrent/metastatic and not amenable to potentially curative surgery. Clinically and/or radiologically documented disease. ECOG 0-1. No prior systemic therapy for metatatic melanoma. No known history of HIV. Patients with active autoimmune disease that requires systemic steroids or immunosuppressive agents are not eligible. Patients with a history of malignancy within 5 years prior to first study drug administration are not eligible. Patients with an allergy to iodinated contrast media used for CT and patients with known history of active TB are not eligible.

Objectives: Primary Objective: to determine if tumour texture measures derived from CT correlates with response. Secondary Objectives: to determine if tumour texture measures derived from CT correlated with time to disease progression; to assess duration of response; to assess overall response rate; to assess overall survival; to compare QALY between pembrolizumab and dacarbazine; to compare QALY between pembrolizumab and ipilimumab; toxicity using CTCAE v4.

NCT Registration ID (from clinicaltrials.gov): NCT02740920
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Closed to Accrual
Activation Date: May 12, 2016 Closing Date: March 12, 2018

Chair: (Canada) Dr. Teresa M. Petrella, Odette Cancer Centre, (416) 480-4662


Closed to Accrual
ME10 (ECOG E1697)Phase III Randomized Study of Four Weeks High Dose IFN-a2b in Stage T2b N0, T3a-bN0, T4a-b N0, and T1-4, N1a, 2a (microscopic) Melanoma
Interferon a-2b has been shown to have some antitumour activity in advanced cases of melanoma. It may also help prevent recurrence of melanoma in patients with a more advanced stage of melanoma. So, it may be helpful in preventing this disease from returning. On the other hand, interferon a-2b has side effects and no treatment so far has been shown to definitely benefit patients with this stage of melanoma. Interferon a-2b is normally produced by the body's immune system. It can now be made in large quantities and so is available for treating patients with cancer. The purpose of this study is to compare any benefit that may possibly be associated with interferon a-2b treatment to that of no treatment after surgery.

Complexity Level: 2

Eligibility: Patients with resected melanoma in the following categories: (1) T3-N0 (1.5-4 mm), (2) T4-N0 (> 4 mm), (3) T1-4 (microscopic, one lymph node positive).

Objectives: To compare the effect of treatment with four weeks of high dose IFN alpha-2b versus observation on relapse free survival and overall survival. Also, toxicities and quality-adjusted survival will be compared in the two groups.

NCT Registration ID (from clinicaltrials.gov): NCT00003641
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 14, 1999 Closing Date: October 26, 2010

Chair: (Canada) Dr. Michael Smylie, Cross Cancer Institute, (780) 432-8757


Closed to Accrual
MEC3 (ECOG E1609)A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy versus High-Dose Interferon a-2b for Resected High-Risk Melanoma
This is a phase III randomized trial targeting a patient population that is at a high and unacceptable risk of recurrence and death after standard surgical management. Patients with resectable high-risk deep cutaneous melanoma, patients with lymph node involvement by melanoma, patients with gross extra-nodal extension of disease, satellites, and/or in-transit lesions, as well as patients with completely resected stage IV disease, have the highest recurrence risk and the poorest disease-free and overall survival rates. This trial is designed to evaluate the recurrence-free survival and overall survival of these patients. Once randomized, patients will be assigned to treatment with either high dose ipilimumab (Arm A), high dose interferon alfa - 2b (Arm B), or low dose ipilimumab (Arm C). All three arms will include an induction and maintenance phase of treatment. The trial was centrally activated on May 25th, 2011, and NCIC CTG plans on centrally activating this trial by April 2012.

Complexity Level: 2

Eligibility: Patients enrolled in this study must have a diagnosis of primary cutaneous melanoma (high risk stage IIIB - IV as per AJCC Melanoma Staging System), and must have completely surgically resected disease at baseline. Patients must have been surgically rendered free of disease with negative margins, and must have a disease free status documented by a complete physical examination and imaging studies within 4 weeks prior to randomization. Some patients with disease recurrence after adequate surgical excision of the original primary melanoma are allowed as well, as specified in the protocol. A total of 1500 patients will be enrolled over 3.3 years. Accrual rate is expected to be 38 per month, and with additional follow up time, a total duration of study is expected to be less than 6 years.

Objectives: Primary Objectives: " To evaluate recurrence-free survival (RFS) between patients randomized to receive post-operative adjuvant ipilimumab given at either 10 mg/kg (high dose ipilimumab; HIP) or 3 mg/kg (low dose ipilimumab: LIP) versus those randomized to receive HDI utilizing a hierarchical design assessing HIP versus HDI first and LIP versus HDI second (if the first comparison is significant). " To evaluate overall survival (OS) between patients randomized to receive post-operative adjuvant ipilimumab given at either 10 mg/kg (HIP) or 3 mg/kg (LIP) versus those randomized to receive HDI utilizing a hierarchical design assessing HIP versus HDI first and LIP versus HDI second (if the first comparison is significant). Secondary Objectives: " To evaluate safety and tolerability of post-operative adjuvant ipilimumab therapy given at either 10 mg/kg (HIP) or 3 mg/kg (LIP).

NCT Registration ID (from clinicaltrials.gov): NCT01274338
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: October 02, 2012 Closing Date: August 15, 2014

Chair: (Canada) Dr. Teresa M. Petrella, Odette Cancer Centre, (416) 480-4662


Closed to Accrual
MEC4 (ALLIANCE A091201)Randomized Phase II Study Comparing the MET Inhibitor Cabozantinib to Temozolomide/Dacarbazine in Ocular Melanoma
The purpose of this phase II study is to find out whether it is better to receive a new drug, Cabozantinib, compared to the standard of treatment, Temozolomide or Dacarbazine, for ocular melonoma.

Complexity Level: 2

Eligibility: Patients with ocular melanoma that is metastatic or unresectable

Objectives: Primary Objective: Compare the progression-free survival rate at 4 months (PFS4) of patients with ocular melanoma treated with cabozantinib or temozolomide / dacarbazine. Secondary Objectives: Estimate the distribution of progression-free survival (PFS) times; Estimate the distribution of overall survival (OS) times; Estimate the confirmed response rate as determined by the RECIST criteria; Assess the safety of these agents by examining the toxicity profile; Correlate the response of MET molecular status.

NCT Registration ID (from clinicaltrials.gov): NCT01835145
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 09, 2015 Closing Date: May 06, 2016

Chair: (Canada) Dr. Marcus Butler, University Health Network, (416) 946-4501 Ext. 5485


Closed to Accrual
MEC5 (SWOG 1404)A Phase III Randomized Trial Comparing Physician/Patient Choice of Either High Dose Interferon or Ipilimumab to MK-3475 (Pembrolizumab) in Patients with High Risk Resected Melanoma
This is a phase III randomized trial targeting a patient population that is at a high and unacceptable risk of recurrence and death after standard surgical management. Patients will be assigned to Arm 1 High dose interferon alfa-2 b (HDI) or Arm 2 pembrolizumab (MK-3475). HDI is the current Health Canada-approved adjuvant treatment. The benefits of HDI remain modest and toxicity can be significant and prolonged. Adjuvant therapy for melanoma with HDI or pembrolizumab (MK-3475) is aimed at inducing an immune response that eradicates micrometastatic tumor deposits that may lead to a future melanoma relapse. This trial is designed to evaluate the recurrence-free survival (RFS) and overall survival (OS) of patients with resected Stage III and IV melanoma treated with HDI and pembrolizumab. RFS and OS will also be measured in the same population depending on PD-L1 status. The trial was activated in the US on October 15th, 2015 and NCIC CTG plans on centrally activating by January 2016.

Complexity Level: 2

Eligibility: Patients enrolled in this study must have completely resected melanoma of cutaneous origin (stage IIIA (N2a), IIIB, IIIC, or Stage IV) or of unknown primary. Patients with melanoma of mucosal or other non-cutaneous origin are eligible except for those with melanoma of ocular origin. Patients with a history of brain metastases are ineligible. For all patients, all disease must have been resected with negative pathological margins and no clinical radiologic or pathological evidence of any incompletely resected melanoma. Patients must be registered with 98 day of the last surgery performed to render the patient free of disease. Accrual rate is expected to be 45 patients per month with a total of 1240 patients enrolled in less than 2.5 years.

Objectives: Primary Objectives: a.Compare overall survival (OS) of patients with resected Stage III and IV melanoma treated with high dose interferon alfa-2b versus MK-3475 (pembrolizumab) b.Among patients who are PD-L1 positive, to compare OS of patients with resected Stage III and IV melanoma treated with high dose interferon alfa-2b versus MK-3475 (pembrolizumab) c.Compare relapse-free survival (RFS) of patients with resected Stage III and IV melanoma treated with high dose interferon alfa-2b to MK-3475 (pembrolizumab) d.Among patients who are PD-L1 positive, to compare RFS of patients with resected Stage III and IV melanoma treated with high dose interferon alfa-2b to MK-3475 (pembrolizumab) Secondary Objectives: a. Estimate OS and RFS for patients who are PD-L1 negative or PD-L1 indeterminate in this population. b. Compare OS and RFS of patients between the two regimens within PD-L1 positive and negative subgroups and to look at the interaction between PD-L1 and treatment arm.

NCT Registration ID (from clinicaltrials.gov): NCT02506153
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: January 15, 2016 Closing Date: November 02, 2017

Chair: (Canada) Dr. Teresa M. Petrella, Odette Cancer Centre, (416) 480-4662


Closed to Accrual
I104NCIC CTG Randomized Phase II Study of Two Schedules of Bryostatin 1 (NSC 339555) in Patients With Advanced Malignant Melanoma


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 05, 1997 Closing Date: October 26, 1998

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


Permanently Closed
I137A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Previously Untreated Metastatic Malignant Melanoma


Eligibility: Patients with malignant melanoma, recurrent and non-curable by surgical or other means. Prior adjuvant immunotherapy permitted. No systemic therapy for relapsed disease (ie, chemotherapy naive).

Objectives: To determine the efficacy and toxicity of flavopiridol given as a one hour IV infusion daily x three days every three weeks in patients with recurrent/metastatic malignant melanoma.

NCT Registration ID (from clinicaltrials.gov): NCT00005971
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: July 04, 2000 Closing Date: July 13, 2001

Permanently Closed
I14NCIC CTG Phase II Study of N-methylformamide in Melanoma


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
I156A Phase II Study of Perifosine in Previously Untreated Patients With Metastatic or Recurrent Malignant Melanoma
The purpose of this research status is to find out what effects an experimental drug, Perifosine, will have on malignant melanoma. Patients who meet all of the eligibility critera listed in the protocol will take Perifosine by mouth every day for 21 days, followed by 7 days without treatment.

Eligibility: Patients with histologically documented malignant melanoma, with metastatic or recurrent disease not curable by other means. Patients may have had prior adjuvant immunotherapy but must NOT have received ANY prior chemotherapy. Disease must be clinically and/or radiologically documented and at least one site of disease must be unidimensionally measurable.

Objectives: To assess the efficacy and toxicity of Perifosine given by mouth for 3 weeks every 4 weeks in previously untreated patients with metastatic or recurrent malignant melanoma.

NCT Registration ID (from clinicaltrials.gov): NCT00053781
Participation: Limited to invited centres only.
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: May 16, 2003 Closing Date: April 26, 2004

Permanently Closed
I169A Phase II Study of SB-715992 (NSC 727990) in Previously Untreated Patients with Metastatic or Recurrent Malignant Melanoma


Eligibility: Patients with histologically documented malignant melanoma with metastatic or recurrent disease. Unidimensionally measurable disease by RECIST criteria. Prior adjuvant immunotherapy permitted; no prior chemotherapy. Patients must be > 4 weeks since major surgery or radiation therapy, and > 3 months since prior adjuvant immunotherapy. Patients must have archival tumour specimen available for correlative study

Objectives: To assess the efficacy and toxicity of SB-715992 given by 1 hour intravenous infusion once every 3 weeks in previously untreated patients with metastatic or recurrent malignant melanoma.

NCT Registration ID (from clinicaltrials.gov): NCT00095953
Participation: Participation in this phase II 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: November 22, 2004 Closing Date: May 01, 2006

Chair: (Canada) Dr. Christopher Lee, BC Cancer Agency - Fraser Valley Centre, (604) 930-4017


Permanently Closed
I189A Phase II Study of Interleukin-21 (rIL-21) in Patients with Metastatic or Recurrent Malignant Melanoma
The main purpose of this study is to find out whether 50ug/kg/day of rIL-21 is safe to give to patients, but most importanly, to study its effectiveness and side-effects when given on 5 consecutive days weeks 1, 3 and 5. Researchers will also look at blood levels to find out how the drug is distrubuted in the blood and to study the effects on the system. Additional research will investigate tissue samples from previously removed melanoma lesions.

Eligibility: Patients with histologically documented malignant melanoma with metastatic or recurrent disease. Unidimensionally measurable disease by RECIST criteria. Prior adjuvant immunotherapy permitted; no prior chemotherapy. Patients must be > 4 weeks since major surgery or radiation therapy, and > 3 months since prior adjuvant immunotherapy. Patients must have archival tumour specimen available for correlative study.

Objectives: To assess the efficacy and toxicity of rIL-21 given by IV push for the first 5 days weeks 1, 3 and 5 at 50ug/kg/day in the first 6 previously untreated patients with metastatic or recurrent malignant melanoma. To characterize the pharmacokinetics of rIL-21 when dosed at 50 ?g/kg/day. To characterize the effects of rIL-21 on lymphocyte cell-count and soluble CD25 in serum as a potential biomarkers for drug activity. To evaluate the immunogenicity of rIL-21, specifically preexisting immunogenicity to the drug and antibody induction during treatment. To assess melanoma antigenic markers for response and non progression on archival tissue from patients enrolled on the study.

NCT Registration ID (from clinicaltrials.gov): NCT00514085
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: July 10, 2007 Closing Date: August 17, 2009

Chair: (Canada) Dr. Teresa M. Petrella, Odette Cancer Centre, (416) 480-4662


Permanently Closed
I202A Randomized Phase II Study of Interleukin-21 (rIL-21) versus Dacarbazine (DTIC) in Patients with Metastatic or Recurrent Melanoma
The main purpose of this study is to compare the effectiveness of rIL-21 given by intravenous injection daily x 5 in weeks 1, 3 and 5 every 8 weeks and dacarbazine given by intravenous injection Day 1 every 3 weeks in patients with metastatic or recurrent incurable malignant melanoma. We will also be looking at side-effects and safety of these two drugs. The main purpose of this study is to find out whether 50ug/kg/day of rIL-21 is safe to give to patients, but most importantly, to study its effectiveness and side-effects when given on 5 consecutive days weeks 1, 3 and 5. Researchers will also look at blood levels to find out how the drug is distrubuted in the blood and to study the effects on the system. Additional research will investigate tissue samples from previously removed melanoma lesions.

Complexity Level: 2

Eligibility: Patients with histologically documented malignant melanoma which is recurrent or metastatic and is not curable by surgical or other means. Unidimensionally measurable disease. Prior adjuvant immunotherapy permitted; no other prior immunotherapy or chemotherapy permitted, except for RAF and MEK-Inhibitors. Patients must be >4 weeks since major surgery or radiation therapy, and >1 month since prior adjuvant immunotherapy. Patients must have archival tumour tissue from their primary and/or metastatic tumour available for correlative study.

Objectives: To compare efficacy of rIL-21 by IV bolus injection daily x 5 in weeks 1,3,and 5 every 8 weeka(Arm 1) & dacarbazine by IV injection Day 1 every 3 weeks(Arm 2)in previously untreated patients with metastatic or recurrent incurable malignant melanoma. The primary efficacy measure for this study is progression free survival. To compare the effect of rIL-21 and dacarbazine on response rate, duration of response, and overall survival. To determine the safety & toxicity profile of rIL-21 & dacarbazine. To characterize the effects of rIL-21 on lymphocyte sub-populations cell-count, dendritic cells sub-population cell counts, circulating miR-155 and soluble CD25 in blood before & after treatment as potential biomarkers for drug activity. To evaluate pre-existing & treatment induced immunogenicity of rIL-21 by measuring antibodies to rIL-21. To assess for pharmacogenomic markers of activity and toxicity. To assess pre-therapeutic markers for response & non-progression on archival specimens.

NCT Registration ID (from clinicaltrials.gov): NCT01152788
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 28, 2010 Closing Date: February 29, 2012

Chair: (Canada) Dr. Kerry J. Savage, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2641, (Canada) Dr. Teresa M. Petrella, Odette Cancer Centre, (416) 480-4662


Permanently Closed
I21NCIC CTG Phase II Study of Menogaril in Melanoma


NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: May 30, 1985 Closing Date: March 15, 1986

Permanently Closed
I26NCIC CTG Phase II Study of Trimetrexate in Melanoma


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: November 06, 1987

Permanently Closed
I34NCIC CTG Phase I Study of Levamisole/Interferon in Melanoma


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: November 13, 1986 Closing Date: May 07, 1987

Permanently Closed
I5NCIC CTG Phase II Study of Spirogermanium in Melanoma


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: June 01, 1983 Closing Date: May 14, 1984

Permanently Closed
I56NCIC CTG Phase II Study of DuP937 in Patients With Melanoma


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: March 07, 1991 Closing Date: April 23, 1992

Permanently Closed
I61NCIC CTG Phase II Study of 10-EDAM in Patients With Metastatic Malignant Melanoma


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: January 08, 1991 Closing Date: January 21, 1992

Permanently Closed
I87A Phase IB Biomodulation Study of Increasing Doses of Weekly Levamisole in the Adjuvant Treatment of Patients With Moderate/High Risk, Localized, Resected Cutaneous Malignant Melanoma


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: June 26, 1995 Closing Date: May 01, 1997

Permanently Closed
I91NCIC CTG Phase I/II Study of BB2516 in Patients with Malignant Melanoma and Cutaneous Metastases


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: August 01, 1995 Closing Date: March 31, 1997

Permanently Closed
ME1NCIC First Cooperative Clinical Trial of Adjuvant Immunotherapy for Malignant Melanoma


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 15, 1978 Closing Date: December 31, 1982

Permanently Closed
ME2NCIC Collaborative Study of Vinblastine, Bleomycin and Cisplatinum in the Treatment of Metastatic Malignant Melanoma


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 11, 1981 Closing Date: June 08, 1982

Permanently Closed
ME3NCIC Study of CCNU, Vincristine and Procarbazine in the Treatment of Metastatic Malignant Melanoma


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: June 30, 1982 Closing Date: September 01, 1983

Permanently Closed
ME5National Intergroup Protocol For Intermediate Thickness Melanomas 1.0 to 4.0mm Evaluation of Optimal Surgical Margins (2 Vs 4cm) Around the Primary Melanoma and Evaluation of Elective Regional Lymph Node Dissection


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: October 01, 1983 Closing Date: March 16, 1993

Chair: (Canada) Dr. Walley Temple, Tom Baker Cancer Centre, (403) 521-3914


Permanently Closed
ME6 (8593)A Randomized Trial of Prophylactic Isolation Perfusion for Stage I High Risk Malignant Melanoma of the Limbs


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: October 30, 1986 Closing Date: June 14, 1988

Permanently Closed
ME7A Comparison of Immunomodulating Doses of Human Interferon Gamma with Levamisole for the Adjuvant Treatment of Poor Prognosis Malignant Melanoma


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: November 04, 1988 Closing Date: May 10, 1990

Chair: (Canada) Dr. James Rusthoven, (905) 648-7936


Permanently Closed
ME8A Double-Blind, Placebo-Controlled, Randomized Phase III Study Comparing the Complete and Partial Response Rates of a Combination of Carmustine (BCNU), Dacarbazine (DTIC) and Cisplatin With and Without Tamoxifen in Patients with Metastatic Melanoma


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 26, 1992 Closing Date: January 31, 1995

Chair: (Canada) Dr. James Rusthoven, (905) 648-7936


Permanently Closed