Status: Closed
Activation Date: 1999SEP14
Closing Date: 2010OCT26
Phase: III
Description: 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
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).
Objective: 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.
Participation: Open to member centres
Lay Description: 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.
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Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| MELANOMA | ME10 | 142 | 4 | 6 | 10 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| MELANOMA | ME10 | 142 | 0 | 0 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| MELANOMA | ME10 | 142 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |