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| Descriptive Information Fields | |||||
| Brief Title † | Vaccine Therapy in Treating Patients With Recurrent or Refractory Metastatic Melanoma | ||||
| Official Title † | Immunization of Patients With Metastatic Melanoma Using Immunodominant Peptides From the Tyrosinase Protein or Tyrosinase Related Protein-1 (TRP1) | ||||
| Brief Summary | RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Giving the vaccine with interleukin-2 or sargramostim may help kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of peptide vaccine with or without adjuvant interleukin-2 or sargramostim in treating patients who have recurrent or refractory metastatic melanoma. |
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| Detailed Description | OBJECTIVES:
OUTLINE: Patients are stratified by HLA status (A1 vs A3 vs A24 vs A31). Patients are assigned to 1 of 4 vaccine groups:
At least 4 to 6 patients are accrued for the peptide alone cohort before beginning accrual on the other cohorts. Any patient who experiences unacceptable toxicity due to adjuvant therapy is taken off study. If a second patient develops unacceptable toxicity, that schedule of peptide administration is discontinued. Patients exhibiting stable, minor, mixed, or partial response may receive up to 12 additional courses. Patients are followed for 4-6 weeks. PROJECTED ACCRUAL: A maximum of 457 patients will be accrued for this study over 3.5 years. |
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Melanoma (Skin) | ||||
| Intervention † | Drug: aldesleukin Drug: incomplete Freund's adjuvant Drug: sargramostim Drug: tyrosinase peptide Drug: tyrosinase-related protein-1 |
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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 † | January 1998 | ||||
| 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:
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| Gender | Both | ||||
| Ages | 16 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00019383 | ||||
| Organization ID | CDR0000065915 | ||||
| Secondary IDs †† | NCI-98-C-0022, NCI-T97-0088 | ||||
| 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 | June 2003 | ||||
| First Received Date † | July 11, 2001 | ||||
| Last Updated Date | October 18, 2008 | ||||