Status:
COMPLETED
Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Vaccines made from a patient's dendritic cells and tumor cells may make the body build an immune response to kill tumor cells. PURPOSE: This phase I trial is studying the side effects and ...
Detailed Description
OBJECTIVES: Primary * Determine the dose-limiting toxicity and the maximum tolerated dose of autologous dendritic cells pulsed with autologous tumor cell lysate in patients with stage III or IV mela...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed melanoma
- Stage III (lymph node or in-transit metastases) or IV (systemic metastases) disease
- Patients with relapsed disease OR who failed prior immunotherapy or chemotherapy are eligible (but trial not restricted to relapsed or refractory disease)
- Tumor tissue available and properly stored for lysate preparation
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- Karnofsky 60-100%
- Life expectancy
- At least 12 weeks
- Hematopoietic
- Absolute neutrophil count ≥ 1,000/mm\^3
- Platelet count ≥ 75,000/mm\^3
- Hepatic
- AST ≤ 2 times upper limit of normal (ULN) (3 times ULN for liver metastases)
- Bilirubin ≤ 2 times ULN
- Hepatitis B surface antigen negative
- Hepatitis C negative
- Renal
- Creatinine ≤ 2.0 times ULN
- Immunologic
- No active infection
- No history of autoimmune disease, including any of the following:
- Inflammatory bowel disease
- Systemic lupus erythematosus
- Scleroderma
- Rheumatoid arthritis
- Multiple sclerosis
- No allergy to aminoglycosides or streptomycin
- HIV negative
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No significant comorbid illness
- No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- See Disease Characteristics
- At least 10 days since prior immunotherapy
- Chemotherapy
- See Disease Characteristics
- Endocrine therapy
- At least 6 weeks since prior steroid therapy
- No concurrent corticosteroids
- Radiotherapy
- At least 10 days since prior radiotherapy
- No concurrent radiotherapy
- Surgery
- At least 10 days since prior surgery
- Prior diagnostic or palliative surgery allowed provided the patient has fully recovered
- Other
- No concurrent immunosuppressive or potentially immunosuppressive therapy
Exclusion
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
End Date :
February 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00085488
Start Date
February 1 2004
End Date
February 1 2006
Last Update
February 2 2015
Active Locations (1)
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1
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002