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| Sponsor: | Mayo Clinic |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006243 |
Purpose
RATIONALE: Vaccines 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.
PURPOSE: This randomized phase I trial is studying giving melanoma vaccine together with sargramostim to see how well it works compared to melanoma vaccine alone in treating patients with stage IV malignant melanoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma (Skin) |
Biological: MART-1 antigen Biological: gp100 antigen Biological: incomplete Freund's adjuvant Biological: sargramostim Biological: tyrosinase peptide |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | Melanoma Vaccines: Differentiation Antigen Peptides (MART-1:27-35, Tyrosinase and gp-100) as Immune Targets |
| Study Start Date: | October 2000 |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are stratified according to dominant disease (visceral vs nonvisceral). Patients are randomized to 1 of 3 treatment arms.
Patients are followed every 3 months until year 3.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, Arizona | |
| Mayo Clinic Scottsdale | |
| Scottsdale, Arizona, United States, 85259 | |
| United States, Florida | |
| Mayo Clinic | |
| Jacksonville, Florida, United States, 32224 | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| Study Chair: | Svetomir Markovic, MD, PhD | Mayo Clinic |
More Information
| ClinicalTrials.gov Identifier: | NCT00006243 History of Changes |
| Other Study ID Numbers: | CDR0000068171, MAYO-9973, NCI-T99-0083 |
| Study First Received: | September 11, 2000 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
|
stage IV melanoma recurrent melanoma |
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue |
Nevi and Melanomas Freund's Adjuvant Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |