S0008: Chemotherapy Plus Biological Therapy in Treating Patients With 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.
Biological: interferon alfa
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- 5-year Overall Survival [ Time Frame: Every three months for a year, every six months for years 2-5, annual for years 5-10 ] [ Designated as safety issue: No ]Overall survival was measured from the date of registration to study until death from any cause with observations censored at the date of last contact for patients last known to be alive.
- 5-year Relapse-Free Survival [ Time Frame: Every three months for the first year, every 6 months for years 2-5, annually for years 6-10 ] [ Designated as safety issue: No ]Measured from date of registration to date of first observation of progressive disease or death due to any cause.
- Toxicity [ Time Frame: While on treatment, patients on the HDIFN arm were assessed weekly for the 1st month, then every 2 weeks for the 2nd month, then every 3 months therafter; patients on the biochemo arm were assessed daily for the 1st 5 days, then weekly thereafter. ] [ Designated as safety issue: Yes ]Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event
|Study Start Date:||August 2000|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Arm I
Patients receive interferon alfa IV on days 1-5 of weeks 1-4 followed by interferon alfa subcutaneously (SC) on days 1, 3, and 5 of weeks 5-52 in the absence of disease progression or unacceptable toxicity.
Biological: interferon alfa
Given IV and subcutaneously
Experimental: Arm II
Patients receive cisplatin IV over 30 minutes followed by vinblastine IV on days 1-4. Patients also receive dacarbazine IV over 1 hour on day 1, interleukin-2 IV over 96 hours on days 1-4, and interferon alfa SC on days 1-5, 8, 10, and 12. In addition, patients receive filgrastim (G-CSF) SC on days 6-15. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Other Name: aldesleukinBiological: filgrastim
Given subcutaneouslyBiological: interferon alfa
Given IV and subcutaneouslyDrug: cisplatin
Given IVDrug: dacarbazine
Given IVDrug: vinblastine
- Compare the overall survival and disease-free survival of patients with high-risk melanoma treated with interferon alfa vs cisplatin, vinblastine, and dacarbazine plus interferon alfa and interleukin-2.
- Compare the toxic effects of these treatment regimens in these patients.
- Determine the relationship between minimal residual disease (MRD) status at 12 weeks and 52 weeks and overall survival of patients treated with these regimens.
- Compare the effects of these treatment regimens on the MRD status of these patients.
- Determine the relationship between clinical characteristics (number of involved lymph nodes, ulcerated primary, and extracapsular extension) and MRD in patients treated with these regimens.
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.
- Arm I: Patients receive interferon alfa IV on days 1-5 of weeks 1-4 followed by interferon alfa subcutaneously (SC) on days 1, 3, and 5 of weeks 5-52 in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive cisplatin IV over 30 minutes followed by vinblastine IV on days 1-4. Patients also receive dacarbazine IV over 1 hour on day 1, interleukin-2 IV over 96 hours on days 1-4, and interferon alfa SC on days 1-5, 8, 10, and 12. In addition, patients receive filgrastim (G-CSF) SC on days 6-15. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
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.
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|Study Chair:||Lawrence E. Flaherty, MD||Barbara Ann Karmanos Cancer Institute|
|Principal Investigator:||John A. Thompson, MD||Seattle Cancer Care Alliance|
|Principal Investigator:||John T. Vetto, MD, FACS||OHSU Knight Cancer Institute|
|Study Chair:||Michael B. Atkins, MD||Beth Israel Deaconess Medical Center|
|Principal Investigator:||John M. Kirkwood, MD||University of Pittsburgh|
|Study Chair:||Frank Haluska, MD, PhD||Massachusetts General Hospital|
|Principal Investigator:||Alberto S. Pappo, MD||Texas Children's Cancer Center|