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| Descriptive Information Fields | |||||
| Brief Title † | Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma | ||||
| 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 | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase I, Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Melanoma (Skin) | ||||
| Intervention † | Drug: MART-1 antigen Drug: aldesleukin Drug: gp100 antigen |
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| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | |||||
| Start Date † | April 1997 | ||||
| Completion Date | |||||
| Eligibility Criteria † | 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
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00019214 | ||||
| Organization ID | CDR0000065234 | ||||
| Secondary IDs †† | NCI-97-C-0046, NCI-97-C-0019, NCI-T96-0046N | ||||
| Study Sponsor † | NCI - Center for Cancer Research-Medical Oncology | ||||
| Collaborators †† | National Cancer Institute (NCI) | ||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | January 2005 | ||||
| First Received Date † | July 11, 2001 | ||||
| Last Updated Date | October 18, 2008 | ||||