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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00019214 |
RATIONALE: Vaccines made from white blood cells treated with antigens may make the body build an immune response to kill melanoma cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining vaccine therapy with interleukin-2 may kill more melanoma cells.
PURPOSE: This phase I/II trial is studying the side effects and how well giving vaccine therapy and interleukin-2 works compared to vaccine therapy alone in treating patients with metastatic melanoma that has not responded to previous therapy.
Condition | Intervention | Phase |
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Melanoma (Skin) |
Biological: MART-1 antigen Biological: aldesleukin Biological: gp100 antigen |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I/II Study in Patients With Metastatic Melanoma of Immunization With Dendritic Cells Presenting Epitopes Derived From The Melanoma Associated Antigens MART-1 and gp 100 |
Study Start Date: | April 1997 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of dendritic cells pulsed with MART-1 and gp100 antigens.
Patients receive vaccinations with dendritic cells pulsed with MART-1 and gp100 antigens, either intralymphatically every 4 weeks for 2 doses, or IV every 3 weeks for 4 doses. Some patients also receive interleukin-2 subcutaneously or IV, over 3-5 days, beginning 24 hours after immunization.
Cohorts of 2-9 patients receive escalating doses of pulsed dendritic cells IV until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Subsequent cohorts receive cells with or without interleukin-2. One cohort may expand to 15 patients to determine the accuracy of immunologic response to the vaccine.
One cohort of 11 patients receives cells intralymphatically without interleukin-2 every 3-4 weeks for 2 courses.
Patients with stable disease or who achieve minor, mixed, or partial response may be retreated.
Patients with stable or responding disease undergo a second course of vaccination. Patients who completed treatment with vaccine alone and have stable disease, progressive disease, disease progression after a response, or a partial response with no further improvement may receive 2 additional courses.
PROJECTED ACCRUAL: A total of 10-42 patients will be accrued for this study.
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:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
Bethesda, Maryland, United States, 20892-1182 |
Study Chair: | James C. Yang, MD | NCI - Surgery Branch |
Study ID Numbers: | CDR0000065234, NCI-97-C-0046, NCI-97-C-0019, NCI-T96-0046N |
Study First Received: | July 11, 2001 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00019214 History of Changes |
Health Authority: | United States: Federal Government |
recurrent melanoma |
Anti-Infective Agents Anti-HIV Agents Antiviral Agents Recurrence Melanoma Neuroendocrine Tumors Neuroectodermal Tumors |
Aldesleukin Anti-Retroviral Agents Interleukin-2 Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Neuroepithelioma Nevus |
Anti-Infective Agents Neoplasms by Histologic Type Anti-HIV Agents Antineoplastic Agents Neoplasms, Nerve Tissue Antiviral Agents Pharmacologic Actions Melanoma |
Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Aldesleukin Anti-Retroviral Agents Neoplasms, Germ Cell and Embryonal Therapeutic Uses Nevi and Melanomas |