Phase III Trial of High Dose Interferon Alfa 2-b Versus Cisplatin, Vinblastine, DTIC Plus IL-2 and Interferon in Patients With High Risk Melanoma
Phase III Trial of High Dose Interferon Alfa 2-b Versus Cisplatin, Vinblastine, DTIC Plus IL-2 and Interferon in Patients With High Risk Melanoma
RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. It is not yet known whether interferon alfa is more effective with or without combination chemotherapy and interleukin-2 for melanoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or without combination chemotherapy consisting of cisplatin, vinblastine, and dacarbazine, plus interleukin-2, in treating patients who have melanoma.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to nodal status (N1 or N2 vs N3), degree of lymph node involvement (micrometastases only vs any macrometastases, including satellite/in-transit metastases), and ulceration of the primary tumor (yes vs no vs unknown primary). Patients are randomized to 1 of 2 treatment arms.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 410 patients (205 per treatment arm) will be accrued for this study within 3 years.
DISEASE CHARACTERISTICS:
Histologically proven melanoma of cutaneous origin or from unknown primary at initial presentation of primary or first clinically detected nodal or satellite/in-transit recurrence
One of the following criteria must apply for patients with newly diagnosed melanoma OR a previously diagnosed primary with current subsequent, clinical, regional nodal disease and/or satellite/in-transit disease:
Ulcerated primary melanoma with 1 or more involved lymph nodes (micro/occult or macro/clinically overt)
Non-ulcerated or unknown primary melanoma with one macro/clinically overt lymph node metastasis, including a single matted nodal mass
Non-ulcerated melanoma with two or more lymph node metastases (micro/occult or macro/clinically overt) and/or matted nodes
Any satellite/in transit metastasis with or without lymph node involvement
Patients with recurrent disease must have recurrent disease in the regional nodal basin of a prior complete lymphadenectomy
Multiple regional nodal basin involvement allowed if they are appropriate anatomic drainage basins for primary site
Patients must be disease free at time of enrollment based on the following surgical criteria:
No more than 56 days since prior lymphadenectomy OR surgery to remove recurrent disease after prior complete lymphadenectomy
Must be willing to participate in minimal residual disease studies if registered on the study on 3/1/2003 or later
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
No congestive heart failure
No coronary artery disease
No serious cardiac arrhythmia
No prior myocardial infarction
Normal cardiac stress test required if any of the following are present:
Pulmonary:
Other:
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No autoimmune disorders or conditions of immunosuppression
No other prior malignancy within the past 5 years except the following:
HIV negative
No known AIDS or HIV-1 associated complex
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
No prior radiotherapy
No concurrent radiotherapy
Surgery:
Other:
Sana Rosa, California 95405, United States
Altanta, Georgia 30322, United States
Elkton MD, Maryland 21921, United States
Lichfield, Minnesota 55355, United States