Melanoma Clinical Trial
Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma
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 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.
Eligibility Criteria
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
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There is 1 Location for this study
Lebanon New Hampshire, 03756, United States
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