Status:
COMPLETED
Vaccine Therapy in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
RATIONALE: Vaccines made from DNA may make the body build an effective immune response to kill tumor cells. PURPOSE: This randomized phase I trial is studying the side effects and best dose of vaccin...
Detailed Description
OBJECTIVES: Primary * Determine the safety and feasibility of vaccination with human and mouse gp100 DNA in patients with stage IIB, IIC, III, or IV melanoma. * Determine the maximum tolerated dose ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed malignant melanoma
- Stage IIB, IIC, III, or IV disease
- Patients with stage III or IV disease who are free of disease after surgical resection\* are eligible
- Patients free of disease after surgical resection\* must have refused high-dose interferon alfa OR experienced recurrent disease during prior treatment with interferon alfa NOTE: \*Patients who underwent surgical resection must have had the surgery within the past year
- HLA-A0201 positive
- No detectable brain metastases
- PATIENT CHARACTERISTICS:
- Age
- Any age
- Performance status
- Karnofsky 80-100%
- Life expectancy
- Not specified
- Hematopoietic
- WBC ≥ 3,000/mm\^3
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 10 g/dL
- No active bleeding
- Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Albumin ≥ 3.5 g/dL
- AST and ALT ≤ 2.5 times ULN
- Lactate dehydrogenase ≤ 2 times ULN
- No clinical history of hepatitis B or C
- Renal
- Creatinine ≤ 2.0 mg/dL
- Immunologic
- No clinical history of HIV
- No clinical history of HTLV-1
- No active infection requiring antibiotics within the past 72 hours
- No history of collagen vascular, rheumatologic, or other autoimmune disorder
- No grade 1 fever within the past 72 hours
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Weight ≥ 25 kg
- No serious underlying medical condition that would preclude study participation
- No preexisting uveal or choroidal eye disease
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- See Disease Characteristics
- More than 4 weeks since prior immunotherapy
- No prior immunization with any class of vaccine containing gp100, including whole cell, shed antigen, or cell lysate vaccines
- Chemotherapy
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
- Endocrine therapy
- No concurrent corticosteroids that would preclude study participation
- Radiotherapy
- More than 4 weeks since prior radiotherapy
- No concurrent radiotherapy
- Surgery
- See Disease Characteristics
- Other
- Recovered from all prior therapy
- No other concurrent medication that would preclude study participation
- No other concurrent investigational agents
- No other concurrent systemic therapy
Exclusion
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00104845
Start Date
September 1 2004
End Date
September 1 2011
Last Update
March 12 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021