Expired Study
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Seattle, Washington 98109


Purpose:

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. PURPOSE: Phase I/II trial to study the effectiveness of biological therapy in treating patients who have metastatic melanoma.


Study summary:

OBJECTIVES: - Assess the safety and toxicity of cellular adoptive immunotherapy using autologous CD8+ antigen-specific T-cell clones in patients with metastatic melanoma. - Estimate the duration of in vivo persistence of adoptively transferred CD8+ antigen-specific cytotoxic T-cell clones in these patients. - Evaluate the antitumor effects of CD8+ antigen-specific T-cell clones in these patients. OUTLINE: Autologous peripheral blood mononuclear cells are harvested and then CD8+ cytotoxic T-lymphocyte (CTL) clones targeting melanosomal antigens are generated ex vivo. Patients receive cellular adoptive immunotherapy comprising autologous CD8+ CTL clones over 30 minutes on day 1. Patients also receive interleukin-2 subcutaneously every 12 hours on days 1-14 of courses 2-3. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients are followed for approximately 1 year after the last infusion. PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histopathologically proven metastatic melanoma - No CNS metastases - HLA-A2 positive - Bidimensionally measurable disease by palpation on clinical exam or radiographic imaging (x-ray, CT scan, or MRI) - Surgically accessible site for tumor cell procurement (skin, subcutaneous nodule, or superficial node) and patient clinically eligible for such surgery PATIENT CHARACTERISTICS: Age - 18 to 75 Performance status - Karnofsky 80-100% Life expectancy - More than 16 weeks Hematopoietic - WBC greater than 4,000/mm^3 - Absolute neutrophil count greater than 2,000/mm^3 - Platelet count greater than 100,000/mm^3 - Hematocrit greater than 30% Hepatic - Bilirubin no greater than 1.6 mg/dL - SGOT no greater than 150 IU (or no greater than 3 times normal) - Prothrombin time no greater than 1.5 times control Renal - Creatinine no greater than 2.0 mg/dL - Calcium no greater than 12 mg/dL Cardiovascular - No congestive heart failure - No clinically significant hypotension - No symptoms of coronary artery disease - No arrhythmia on EKG requiring drug therapy Pulmonary - No severe chronic obstructive pulmonary disease - FEV_1 at least 1.0 L - DLCO at least 45% of predicted Other - No active infection or oral temperature greater than 38.2 degrees C within 72 hours of study - No systemic infection requiring chronic maintenance or suppressive therapy - HIV negative - No history of seizures - No retinitis or choroiditis - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use adequate contraception - Peripheral blood samples available weekly for 4 consecutive weeks PRIOR CONCURRENT THERAPY: Biologic therapy - At least 4 weeks since other prior immunotherapy Chemotherapy - 1 or 2 courses of cytoreductive chemotherapy allowed for bulky disease - At least 4 weeks since prior standard or investigational chemotherapy Endocrine therapy - At least 4 weeks since prior steroid therapy Radiotherapy - At least 4 weeks since prior radiotherapy Surgery - Not specified Other - At least 4 weeks since other prior investigational drug therapy and recovered


NCT ID:

NCT00002786


Primary Contact:

Study Chair
Cassian Yee, MD
Fred Hutchinson Cancer Research Center


Backup Contact:

N/A


Location Contact:

Seattle, Washington 98109
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 24, 2017

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