Melanoma Clinical Trial
Fludarabine Followed By Adoptive Immunotherapy in Treating Patients With Stage IV Melanoma
Summary
RATIONALE: Biological therapies such as cellular adoptive immunotherapy use different ways to stimulate the immune system and stop cancer cells from growing. Fludarabine may help the immune system kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of fludarabine followed by cellular adoptive immunotherapy in treating patients who have metastatic melanoma.
Full Description
OBJECTIVES:
Primary
Determine the safety and toxicity of adoptive immunotherapy comprising autologous CD8+ antigen-specific cytotoxic T-lymphocyte (CTL) clones after fludarabine in patients with stage IV melanoma.
Determine the duration of in vivo persistence of these CTL clones in these patients.
Secondary
Determine the antitumor effect of this regimen in these patients.
OUTLINE: This is an open-label, nonrandomized study.
Patients undergo leukapheresis or weekly phlebotomy for the collection of peripheral blood mononuclear cells from which autologous antigen-specific CD8+ cytotoxic T-lymphocyte (CTL) clones are generated. Patients receive autologous antigen-specific CD8+ CTL clones IV over 30-60 minutes on days 0 and 21 in the absence of rapid disease progression or unacceptable toxicity. Patients also receive fludarabine IV once daily on days 14-18.
Patients are followed for up to 1 year.
PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study within 3 years.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic melanoma
Stage IV disease
HLA-A2 or -A3-expressing disease
Bidimensionally measurable residual disease by palpation or radiographic imaging (e.g., x-ray or CT scan)
No CNS metastases
Previously treated CNS involvement allowed provided there is no evidence of CNS disease at least 2 months after completion of therapy
PATIENT CHARACTERISTICS:
Age
18 to 75
Performance status
Karnofsky 80-100%
Life expectancy
More than 6 months
Hematopoietic
Platelet count > 100,000/mm^3
Absolute neutrophil count > 2,000/mm^3
Hepatic
SGOT no greater than 3 times upper limit of normal
Bilirubin no greater than 1.6 mg/dL
INR no greater than 1.5 times normal
Renal
Creatinine no greater than 2.0 mg/dL OR
Creatinine clearance at least 60 mL/min
Cardiovascular
No congestive heart failure
No clinically significant hypotension
No symptoms of coronary artery disease
No cardiac arrhythmia by EKG requiring drug therapy
Pulmonary
No clinically significant pulmonary dysfunction
FEV_1 at least 1.0 L*
DLCO at least 45%* NOTE: *For patients with a history of pulmonary dysfunction
Immunologic
No active infection
No oral temperature greater than 38.2°C within the past 48 hours
No systemic infection requiring chronic maintenance or suppressive therapy
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
No concurrent immunotherapy (e.g., interleukins, interferons, melanoma vaccines, IV immunoglobulins, expanded polyclonal tumor-infiltrating lymphocytes, or lymphokine-activated killer therapy)
Chemotherapy
At least 3 weeks since prior chemotherapy (standard or experimental)
Endocrine therapy
No concurrent steroids
Radiotherapy
At least 3 weeks since prior radiotherapy
Surgery
Not specified
Other
At least 3 weeks since prior immunosuppressive therapy
No concurrent pentoxifylline
No other concurrent investigational agents
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There is 1 Location for this study
Seattle Washington, 98109, United States
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