S0008: Chemotherapy Plus Biological Therapy in Treating Patients With Melanoma
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|ClinicalTrials.gov Identifier: NCT00006237|
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : September 19, 2012
Last Update Posted : March 25, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Biological: interleukin-2 Biological: filgrastim Biological: interferon alfa Drug: cisplatin Drug: dacarbazine Drug: vinblastine||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||432 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2000|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
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: aldesleukin
Biological: interferon alfa
Given IV and subcutaneously
- 5-year Overall Survival [ Time Frame: Every three months for a year, every six months for years 2-5, annual for years 5-10 ]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 ]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. ]Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006237
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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|