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Sponsors and Collaborators: |
Herbert Irving Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00037037 |
RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may kill more tumor cells.
PURPOSE: Randomized phase I trial to study the effectiveness of vaccine therapy with or without sargramostim in treating patients who have metastatic melanoma.
Condition | Intervention | Phase |
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Melanoma (Skin) |
Drug: MAGE-10.A2 Drug: MART-1 antigen Drug: NY-ESO-1 peptide vaccine Drug: sargramostim Drug: tyrosinase peptide |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | A Phase I Study of Peptide Based Vaccine Therapy in Patients With High-Risk or Metastatic Melanoma |
Study Start Date: | October 2001 |
OBJECTIVES:
OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 2 treatment arms.
Treatment in both arms continues through week 6 in the absence of disease progression or unacceptable toxicity.
Patients are followed at 2 weeks.
PROJECTED ACCRUAL: A total of 20 patients (10 per treatment arm) will be accrued for this study within 18 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed high-risk stage III or IV melanoma
Stage III disease less than 6 months after surgical resection
Stage III disease at least 6 months after surgical resection
Stage IV disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, New York | |
Herbert Irving Comprehensive Cancer Center at Columbia University | |
New York, New York, United States, 10032 |
Study Chair: | Kyriakos P. Papadopoulos, MD | Herbert Irving Comprehensive Cancer Center |
Study ID Numbers: | CDR0000069357, CPMC-IRB-13824, LUDWIG-LUD00-025, NCI-G02-2068 |
Study First Received: | May 13, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00037037 |
Health Authority: | United States: Federal Government |
stage III melanoma stage IV melanoma recurrent melanoma |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Nevus Recurrence Neuroendocrine Tumors Melanoma |
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas |