Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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 best dose of vaccine therapy in treating patients with stage III or stage IV melanoma.
Full 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 melanoma.
- Determine the safety and tolerability of this therapy in these patients.
Secondary
- Determine the immune response, in terms of the type and degree of T-cell proliferation and delayed-type hypersensitivity responses, in patients treated with this therapy.
OUTLINE: This is a dose-escalation, pilot study.
Patients undergo leukapheresis for the collection of peripheral blood mononuclear cells (PBMC) on days -9, 19, and 47. Autologous dendritic cells (DC) are prepared from autologous PBMC exposed to sargramostim (GM-CSF), interleukin-4, and tumor necrosis factor alpha and pulsed with autologous tumor cell lysate. Patients receive autologous tumor cell lysate-pulsed DC IV over 5-10 minutes on days 0, 28, and 56.
Cohorts of 3-6 patients receive escalating doses of autologous tumor cell lysate-pulsed DC until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 33% of all patients experience dose-limiting toxicity.
Patients are followed at day 84 and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 3-20 patients will be accrued for this study within 3-20 months.
Sex
Ages
Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
-
Histologically confirmed melanoma
- Stage III (lymph node or in-transit metastases) or IV (systemic metastases) disease
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Patients with relapsed disease OR who failed prior immunotherapy or chemotherapy are eligible (but trial not restricted to relapsed or refractory disease)
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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
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No active infection
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No history of autoimmune disease, including any of the following:
- Inflammatory bowel disease
- Systemic lupus erythematosus
- Scleroderma
- Rheumatoid arthritis
- Multiple sclerosis
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No allergy to aminoglycosides or streptomycin
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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
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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