Eastern Cooperative Oncology Group:
99-006 (ECOG - E1697) Trial for Patients With Intermediate Risk Melanoma.
You can learn more about this trial by viewing a short informational video
featuring Dr. Sanjiv Agarwala, the principal investigator for this trial:
Real Media Video
Windows Media Video
Click here for a list of institutions participating in this trial
This phase III clinical trial is designed for patients diagnosed with malignant melanoma that has been treated with surgery. However, it is possible that the melanoma could return.
In addition to surgery, there is no effective treatment that is known at present for your melanoma. The purpose of this study is to compare any benefit that may possibly be associated with receiving interferon alpha-2b treatment following surgery to that of observation only.
Interferon alpha-2b is normally produced by the body's immune system. It is a family of proteins that come from human cells and are involved in fighting infections. Studies have shown Interferon alpha-2b to be effective against some advanced cases of melanoma and to help prevent recurrence of melanoma in patients with more advanced stages of melanoma than yours. It may also be helpful in preventing your disease from returning.
Patients who choose to participate in this study will be randomized into two groups:
- Group A will receive no additional treatment but be closely observed with periodic routine tests to monitor status. Tests will include regular physical examinations, blood tests and a chest x-ray and CT scan of the liver if clinically indicated.
- Group B will receive Interferon alpha-2b intravenously through a needle in the vein to be given over 20 minutes, 5 times a week, Monday-Friday, for four weeks. Following the completion of your injections, follow-up visits to your physician will occur every 3 months for the first two years, then every 6 months for another 3 years, and then annually for 15 years from study entry.
This schedule of follow-up is recommended for your disease whether you take treatment or not.
This study will also evaluate your quality of life before and during treatment. You will be asked to answer some questions about your feelings about activities of your daily life and your sense of enjoyment of activities. These results may be helpful to patients and physicians in the future as they make decisions regarding the appropriateness of interferon therapy for prevention of melanoma relapse and mortality.
You can find additional information about melanoma and its treatment at the following web sites:
National Cancer Institute Melanoma Information
Information about cancer clinical trials can be found at:
National Cancer Institute Clinical Trials Information
CancerTrials Help - Coalition of National cancer Cooperative Groups