Status:
COMPLETED
Lymphocyte-Depleting Nonmyeloablative Preparative Chemotherapy Followed By Autologous Lymphocyte Infusion, Peptide Vaccine Plus Montanide ISA-51, and Interleukin-2 in Treating Patients With Metastatic Melanoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Treating a person's lymphocytes i...
Detailed Description
OBJECTIVES: Primary * Determine the clinical tumor regression in patients with metastatic melanoma treated with a lymphocyte-depleting nonmyeloablative preparative chemotherapy regimen followed by a...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of metastatic melanoma that is refractory to standard therapy (including high-dose interleukin-2)
- Measurable disease
- HLA-A\*0201 positive
- Epstein-Barr virus positive
- ESO-1-expressing disease by reverse transcription polymerase chain reaction amplified tissue OR presence of ESO-1 serum antibody
- PATIENT CHARACTERISTICS:
- Age
- 16 and over
- Performance status
- ECOG 0-1
- Life expectancy
- More than 3 months
- Hematopoietic
- Absolute neutrophil count \> 1,000/mm\^3
- Platelet count \> 100,000/mm\^3
- Hemoglobin \> 8.0 g/dL
- Hepatic
- Hepatitis B surface antigen negative
- Hepatitis C antibody negative
- AST and ALT \< 3 times upper limit of normal
- Bilirubin ≤ 2.0 mg/dL (\< 3.0 mg/dL for patients with Gilbert's syndrome)
- No coagulation disorders
- Renal
- Creatinine ≤ 2.0 mg/dL
- Cardiovascular
- No prior myocardial infarction
- No major cardiovascular illness by stress thallium or comparable test
- No cardiac arrhythmias
- LVEF ≥ 45%
- Normal cardiac stress test required for the following conditions:
- Prior EKG abnormalities
- Symptoms of cardiac ischemia
- Arrhythmias
- Age 50 and over
- Pulmonary
- FEV\_1 \> 60% of predicted (for patients with a prolonged history of cigarette smoking or symptoms of respiratory dysfunction)
- No obstructive or restrictive pulmonary disease
- No other major respiratory illness
- Immunologic
- HIV negative
- No active systemic infection
- No opportunistic infection
- No major immune system illness
- No form of primary or secondary immunodeficiency
- No known hypersensitivity to study agents
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 4 months after study participation
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- See Disease Characteristics
- Prior ESO-1-based vaccination allowed
- Chemotherapy
- At least 6 weeks since prior nitrosoureas and recovered
- Endocrine therapy
- No concurrent systemic steroid therapy
- Radiotherapy
- Recovered from prior radiotherapy
- Surgery
- Not specified
- Other
- At least 4 weeks since prior systemic therapy
Exclusion
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00079144
Start Date
January 1 2004
End Date
August 1 2005
Last Update
June 19 2013
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 - Center for Cancer Research
Bethesda, Maryland, United States, 20892