Expired Study
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Dallas, Texas 75246


Purpose:

RATIONALE: Vaccines made from a patient's white blood cells mixed with tumor antigens may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma.


Study summary:

OBJECTIVES: - Determine the safety and tolerability of antigen-pulsed dendritic cell vaccine in patients with metastatic melanoma. - Determine the longevity of melanoma-specific immunity in patients treated with this regimen. - Perform serial analysis of T-cell and B-cell function in patients treated with this regimen. OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily on days 1-6 or 1-7. Patients undergo apheresis on days 6 and 7 or 6-8 to obtain peripheral blood mononuclear cells (PBMC). PBMC are processed for CD34+ cell isolation. These autologous CD34+ hematopoietic progenitor cells are cultured to generate dendritic cells (DC). DC are then pulsed with endotoxin-free keyhole limpet hemocyanin and HLA-A2-01 restricted flu-matrix peptides derived from melanoma-associated tumor antigens (MART-1:27-35, gp100:209-217, and MAGE-3). Antigen-pulsed DC are incubated with interferon alfa to induce DC maturation. Patients receive priming injections of antigen-pulsed DC vaccine SC once every 2 weeks for 8 weeks. Treatment repeats at 2, 3, 4, and 5 months after the last priming injection in the absence of unacceptable toxicity or disease progression. Patients are followed at 2 and 4 weeks and then every 3 months for 1.5 years. PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed metastatic melanoma - HLA-A2-01 phenotype - Measurable disease - No active CNS or hepatic metastases PATIENT CHARACTERISTICS: Age: - 21 and over Performance status: - Karnofsky 80-100% Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - See Disease Characteristics - No viral hepatitis Renal: - Not specified Cardiovascular: - No prior venous thrombosis, angina pectoris, or congestive heart failure - Lactate dehydrogenase less than 2 times normal Pulmonary: - No prior asthma Immunologic: - Intradermal skin test positivity to mumps, Candida, or streptokinase antigen - No known sensitivity to E. coli drug preparations - No prior allergy to influenza vaccine - No active infection - No prior autoimmune disease (e.g., lupus erythematosus, rheumatoid arthritis, or thyroiditis) Other: - HIV negative - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 8 weeks since prior interleukin-2 - At least 4 weeks since prior interferon alfa Chemotherapy: - At least 8 weeks since prior chemotherapy Endocrine therapy: - At least 2 weeks since prior corticosteroids - No concurrent corticosteroids Radiotherapy: - Not specified Surgery: - Not specified Other: - No concurrent immunosuppressive agents - At least 2 weeks since prior immunosuppressive agents


NCT ID:

NCT00017355


Primary Contact:

Study Chair
Joseph W. Fay, MD
Baylor Health Care System


Backup Contact:

N/A


Location Contact:

Dallas, Texas 75246
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 21, 2017

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