Status:
TERMINATED
Cyclophosphamide and Fludarabine Followed By an Autologous Lymphocyte Infusion and Interleukin-2 in Treating Patients With Refractory or Recurrent Metastatic Melanoma
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: An infusion of a patient's lymphocytes that have been treated in the laboratory to remove certain immune cells may be an effective treatment for melanoma. Drugs, such as cyclophosphamide an...
Detailed Description
OBJECTIVES: Primary * Determine tumor regression in patients with metastatic melanoma treated with nonmyeloablative lymphodepleting chemotherapy comprising cyclophosphamide and fludarabine followed ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of melanoma
- Metastatic disease
- Measurable disease
- HLA-A2 negative disease
- Disease did not respond to OR recurred after completion of prior high-dose interleukin-2 (IL-2)
- Eligible to receive high-dose IL-2
- No tumor reactive cells available for cell transfer therapy
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- ECOG 0-1
- Life expectancy
- At least 3 months
- Hematopoietic
- Absolute neutrophil count \> 1,000/mm\^3
- Platelet count \> 100,000/mm\^3
- Hemoglobin \> 8.0 g/dL
- No coagulation disorders
- Hepatic
- ALT and AST \< 3 times upper limit of normal
- Bilirubin ≤ 2.0 mg/dL (\< 3.0 mg/dL if due to Gilbert's syndrome)
- Hepatitis B surface antigen negative
- Hepatitis C antigen negative
- Renal
- Creatinine ≤ 2.0 mg/dL
- No renal failure requiring dialysis due to toxic effects of prior IL-2 administration
- Cardiovascular
- No myocardial infarction
- No cardiac arrhythmias
- No other major cardiovascular illness as evidenced by a positive stress thallium or comparable test
- Normal cardiac stress test (e.g., stress thallium, stress MUGA, dobutamine echocardiogram) AND LVEF ≥ 45% (for patients ≥ 50 years of age or who have a history of EKG abnormalities, symptoms of cardiac ischemia, or arrhythmias)
- Pulmonary
- No obstructive or restrictive pulmonary disease
- No other major respiratory illness
- FEV\_1 ≥ 60% of predicted (for patients with a prolonged history of cigarette smoking or symptoms of respiratory dysfunction)
- Immunologic
- HIV negative
- Epstein-Barr virus positive
- No active systemic infection
- No autoimmune disease (e.g., autoimmune colitis or Crohn's disease)
- No immunodeficiency due to prior chemotherapy or radiotherapy
- Recovered immune competence after prior chemotherapy or radiotherapy as evidenced by normal lymphocyte count and WBC and an absence of opportunistic infection
- No other major immune system disease
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 4 months after completion of study treatment
- No other toxic effects during prior IL-2 administration that would preclude redosing with IL-2, including the following:
- Mental status changes that would require intubation
- Bowel perforation
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- See Disease Characteristics
- At least 4 weeks since prior systemic therapy
- Chemotherapy
- At least 6 weeks since prior nitrosoureas
- At least 4 weeks since prior systemic therapy
- Endocrine therapy
- No concurrent systemic steroid therapy
- Radiotherapy
- Not specified
- Surgery
- Not specified
Exclusion
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00138229
Start Date
July 1 2005
End Date
April 1 2007
Last Update
March 29 2012
Active Locations (2)
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1
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
2
NCI - Surgery Branch
Bethesda, Maryland, United States, 20892-1201