Status:
COMPLETED
Fludarabine Followed By Adoptive Immunotherapy in Treating Patients With Stage IV Melanoma
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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 kil...
Detailed 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 s...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2008
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00317759
Start Date
May 1 2003
End Date
October 1 2008
Last Update
October 1 2015
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024