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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) Eastern Cooperative Oncology Group Cancer and Leukemia Group B Children's Oncology Group |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006237 |
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 | Intervention | Phase |
Melanoma (Skin) |
Drug: aldesleukin Drug: cisplatin Drug: dacarbazine Drug: filgrastim Drug: recombinant interferon alfa Drug: vinblastine |
Phase III |
MedlinePlus related topics: | Cancer Melanoma |
ChemIDplus related topics: | Filgrastim Cisplatin Dacarbazine Aldesleukin Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Interferons Vinblastine Vinblastine sulfate |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
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 |
Estimated Enrollment: | 410 |
Study Start Date: | August 2000 |
Arms | Assigned Interventions |
Arm I: Active Comparator
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.
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Drug: recombinant interferon alfa
Given IV and subcutaneously
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Arm II: Experimental
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.
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Drug: aldesleukin
Given IV
Drug: cisplatin
Given IV
Drug: dacarbazine
Given IV
Drug: filgrastim
Given subcutaneously
Drug: recombinant interferon alfa
Given IV and subcutaneously
Drug: vinblastine
Given IV
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
Non-ulcerated or unknown primary melanoma with one macro/clinically overt lymph node metastasis, including a single matted nodal mass
Patients must be disease free at time of enrollment based on the following surgical criteria:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Normal cardiac stress test required if any of the following are present:
Pulmonary:
Other:
No other prior malignancy within the past 5 years except the following:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
No prior radiotherapy
Surgery:
Other:
Show 297 Study Locations |
Southwest Oncology Group |
National Cancer Institute (NCI) |
Eastern Cooperative Oncology Group |
Cancer and Leukemia Group B |
Children's Oncology Group |
Study Chair: | Lawrence E. Flaherty, MD | Barbara Ann Karmanos Cancer Institute |
Investigator: | John A. Thompson, MD | Seattle Cancer Care Alliance |
Investigator: | John T. Vetto, MD, FACS | Oregon Health and Science University Cancer Institute |
Study Chair: | Michael B. Atkins, MD | Beth Israel Deaconess Medical Center |
Investigator: | John M. Kirkwood, MD | UPMC Cancer Centers |
Study Chair: | Frank Haluska, MD, PhD | Massachusetts General Hospital |
Investigator: | Alberto S. Pappo, MD | Texas Children's Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000068162, SWOG-S0008, CALGB-500002, ECOG-S0008, COG-S0008 |
First Received: | September 11, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00006237 |
Health Authority: | United States: Federal Government |
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