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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) Southwest Oncology Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005034 |
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow or peripheral blood. It is not yet known which treatment regimen is more effective for melanoma.
PURPOSE: This randomized phase III trial is studying peptide vaccine therapy and/or sargramostim and comparing how well they work in treating patients with locally advanced or metastatic melanoma.
Condition | Intervention | Phase |
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Intraocular Melanoma Melanoma (Skin) |
Biological: MART-1 antigen Biological: gp100 antigen Biological: incomplete Freund's adjuvant Biological: sargramostim Biological: tyrosinase peptide Procedure: adjuvant therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Official Title: | A Randomized, Placebo-Controlled Phase III Trial of Yeast Derived GM-CSF Versus Peptide Vaccination Versus GM-CSF Plus Peptide Vaccination Versus Placebo in Patients With "No Evidence of Disease" After Complete Surgical Resection of "Locally Advanced" and/or Stage IV Melanoma |
Estimated Enrollment: | 800 |
Study Start Date: | December 1999 |
OBJECTIVES:
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified by HLA-A2 status (positive vs negative), site of metastases this occurrence (visceral vs nonvisceral vs visceral and nonvisceral vs no metastases), and number of metastases this occurrence (1 vs 2 or 3 vs 4 or more vs 0).
Patients are assigned to one of two treatment groups based on HLA-A2 status.
Group A (HLA-A2 positive): Patients are randomized to 1 of 4 treatment arms.
Group B (HLA-A2 negative): 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 up to 10 years.
PROJECTED ACCRUAL: A total of 800 patients will be accrued for this study within 4.4 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven completely resected melanoma including one of the following:
Stage IV disease including:
If ineligible for SWOG-0008 or are determined by managing physician to be medically unfit to receive standard high-dose interferon, patients with one of the following may be eligible:
Rendered free of disease with negative margins by surgical means only
Must be randomized within 16 weeks of surgical resection
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
No other malignancy within the past 5 years except any of the following curatively treated cancers:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
One prior systemic regimen after prior surgery allowed if completed at least 8 weeks ago
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study ID Numbers: | CDR0000067568, ECOG-4697, SWOG-E4697 |
Study First Received: | April 6, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00005034 History of Changes |
Health Authority: | United States: Federal Government |
iris melanoma ciliary body and choroid melanoma, medium/large size extraocular extension melanoma recurrent intraocular melanoma |
stage III melanoma stage IV melanoma recurrent melanoma |
Immunologic Factors Eye Neoplasms Uveal Melanoma Eye Diseases Adjuvants, Immunologic Melanoma of the Choroid Recurrence Melanoma |
Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Intraocular Melanoma Neuroepithelioma Freund's Adjuvant Nevus |
Neoplasms by Histologic Type Immunologic Factors Eye Neoplasms Eye Diseases Physiological Effects of Drugs Neoplasms, Nerve Tissue Adjuvants, Immunologic Pharmacologic Actions |
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Neoplasms by Site Neoplasms, Germ Cell and Embryonal Nevi and Melanomas Freund's Adjuvant |