Expired Study
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Lebanon, New Hampshire 03756


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.

Study summary:

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.


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



Primary Contact:

Study Chair
Christopher P. Tretter, MD
Norris Cotton Cancer Center

Backup Contact:


Location Contact:

Lebanon, New Hampshire 03756
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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