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| Sponsors and Collaborators: |
NCI - Center for Cancer Research-Medical Oncology National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00019994 |
Purpose
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma that has not responded to previous therapy.
| Condition | Intervention | Phase |
|
Melanoma (Skin) |
Drug: MART-1 antigen Drug: aldesleukin Drug: gp100 antigen Drug: incomplete Freund's adjuvant |
Phase II |
| MedlinePlus related topics: | Cancer Melanoma |
| Drug Information available for: | Aldesleukin Freund's adjuvant Montanide ISA 51 |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Immunization of Patients With Metastatic Melanoma Using a Class II Restricted Peptide From the GP100 Antigen and Class I Restricted Peptides From the GP100 and MART-1 Antigens |
| Study Start Date: | October 1999 |
OBJECTIVES:
OUTLINE: Patients are assigned to one of three immunization groups based on HLA-A0201 status and prior gp100:209-217 (210M) antigen peptide immunization:
Patients are followed at 3-4 weeks.
PROJECTED ACCRUAL: A total of 45-75 patients (15-25 per immunization group) will be accrued for this study within 2 years.
Eligibility
| Ages Eligible for Study: | 16 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:
Immunologic:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Maryland | |||||
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |||||
| Bethesda, Maryland, United States, 20892-1182 | |||||
| NCI - Center for Cancer Research-Medical Oncology |
| National Cancer Institute (NCI) |
| Study Chair: | Steven A. Rosenberg, MD, PhD | NCI - Surgery Branch |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000067391, NCI-99-C-0159, NCI-T99-0079 |
| First Received: | July 11, 2001 |
| Last Updated: | October 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00019994 |
| Health Authority: | United States: Federal Government |
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