Status:
COMPLETED
Vaccine Therapy in Treating Patients With Metastatic Melanoma
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Intraocular Melanoma
Melanoma (Skin)
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill melanoma cells. PURPOSE: This phase II trial is study...
Detailed Description
OBJECTIVES: Primary * Determine clinical response in HLA-A \*0201-positive patients with metastatic melanoma treated with an intradermally administered vaccine comprising autologous dendritic cells ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of melanoma
- Metastatic disease
- The following melanoma subtypes are eligible:
- Unresectable, stage III-IV uveal melanoma
- Metastatic mucosal melanoma
- Measurable disease after attempted curative surgical therapy
- Tumor tissue must be available for immunohistochemical staining
- Positive for ≥ 1 of the following peptides:
- MART-1: 26-35 (27L)
- gp100: 209-217 (210M)
- Tyrosinase: 368-376 (370D)
- HLA-A \*0201 positive by DNA polymerase chain reaction assay
- PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
- Creatinine ≤ 2.0 mg/dL
- Bilirubin ≤ 2.0 mg/dL
- WBC ≥ 3,000/mm\^3
- Platelet count ≥ 75,000/mm\^3
- Hemoglobin ≥ 9.0 g/dL
- No major systemic infections
- No coagulation disorders
- No major medical illness of the cardiovascular or respiratory system
- No myocardial infarction within the past 6 months
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No known HIV positivity
- No know positivity for hepatitis B surface antigen or hepatitis C antibody
- No prior uveitis or autoimmune inflammatory eye disease
- No other prior malignancy except cervical carcinoma in situ or basal cell skin cancer unless patient was curatively treated \> 5 years ago and has no detectable disease
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No more than 1 prior cytotoxic chemotherapy agent or regimen
- Prior biologic or antiangiogenic therapies allowed
- More than 1 month since prior and no concurrent radiotherapy, chemotherapy, adjuvant therapy, or any other therapy for melanoma
- No prior MART-1: 26-35 (27L), gp100: 209-217 (210M), or tyrosinase: 368-376 (370D) peptides
- No concurrent steroid therapy
Exclusion
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2005
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00334776
Start Date
October 1 2003
End Date
June 1 2005
Last Update
May 21 2014
Active Locations (2)
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1
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
2
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942