Melanoma Clinical Trial
Biological Therapy in Treating Patients With Metastatic Melanoma
Summary
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.
Full Description
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.
Eligibility 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
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There is 1 Location for this study
Seattle Washington, 98109, United States
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