Biological Therapy in Treating Patients With Metastatic Melanoma

Fred Hutchinson Cancer Center20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Melanoma (Skin)

Interventions

aldesleukinBIOLOGICAL

therapeutic tumor infiltrating lymphocytesBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Data from ClinicalTrials.gov

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