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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006385 |
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Biological therapies such as sargramostim and interferon alfa use different ways to stimulate the immune system and stop cancer cells from growing. It is not yet known if vaccine therapy if more effective with or without biological therapy for melanoma.
PURPOSE: Randomized phase II trial to compare the effectiveness of vaccine therapy with or without biological therapy in treating patients who have metastatic melanoma.
Condition | Intervention | Phase |
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Melanoma (Skin) |
Drug: MART-1 antigen Drug: gp100 antigen Drug: incomplete Freund's adjuvant Drug: recombinant interferon alfa Drug: sargramostim Drug: tyrosinase peptide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Phase II Evaluation of Immunization With an HLA-A2 Multi-Epitope Peptide Vaccine Containing MART-1 (NSC #672643), gp100 (NSC #683472), and Tyrosinase (NSC #699048) Peptides Alone or in Combination With GM-CSF, IFN Alpha-2b, or GM-CSF + IFN Alpha-2b in Patients With Metastatic Melanoma |
Study Start Date: | September 2000 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study.
Patients are randomized to 1 of 4 treatment arms.
Treatment continues every 4 weeks for a maximum of 13 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 thereafter.
PROJECTED ACCRUAL: A total of 92 patients (23 per arm) will be accrued for this study within 13-16 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Measurable disease
No brain disease by MRI or CT scan within 4 weeks prior to randomization
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
No other malignancy within the past 5 years except:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Study Chair: | John M. Kirkwood, MD | UPMC Cancer Centers |
Study ID Numbers: | CDR0000068263, E-1696 |
Study First Received: | October 4, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00006385 |
Health Authority: | United States: Federal Government |
stage IV melanoma recurrent melanoma |
Interferon-alpha Interferon Type I, Recombinant Interferons Recurrence Melanoma Neuroendocrine Tumors Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Neuroepithelioma Freund's Adjuvant Nevus Interferon Alfa-2a Interferon Alfa-2b |
Anti-Infective Agents Neoplasms by Histologic Type Immunologic Factors Antineoplastic Agents Growth Substances Neoplasms, Nerve Tissue Physiological Effects of Drugs Adjuvants, Immunologic |
Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Therapeutic Uses Nevi and Melanomas Growth Inhibitors Angiogenesis Modulating Agents |