Status:
COMPLETED
Cyclophosphamide, Fludarabine, and Total-Body Irradiation Followed By Cellular Adoptive Immunotherapy, Autologous Stem Cell Transplantation, and Interleukin-2 in Treating Patients With 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: 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. Radiation therapy uses high-energ...
Detailed Description
OBJECTIVES: Primary * Determine complete clinical tumor regression in patients with metastatic melanoma treated with a myeloablative lymphoid-depleting preparative regimen comprising cyclophosphamid...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of metastatic melanoma
- Measurable disease
- Resected or stable brain metastases are allowed
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- Eastern Cooperative Oncology Group (ECOG) 0-1
- Life expectancy
- At least 3 months
- Hematopoietic
- See Immunologic
- Absolute neutrophil count \> 1,000/mm\^3 (without support of filgrastim \[G-CSF\])
- Platelet count \> 100,000/mm\^3
- Hemoglobin ≥ 8 g/dL (transfusion allowed)
- No coagulation disorders
- Hepatic
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 3 times upper limit of normal
- Bilirubin ≤ 2 mg/dL (\< 3 mg/dL in patients with Gilbert's syndrome)
- No hepatitis B or C
- Renal
- Creatinine ≤ 1.6 mg/dL
- Cardiovascular
- Left ventricular ejection fraction (LVEF) ≥ 45% by cardiac stress test\*
- No active major cardiovascular illness as evidenced by stress thallium or other comparable test
- No myocardial infarction
- No cardiac arrhythmias NOTE: \*For patients ≥ 50 years of age receiving high-dose interleukin-2 (IL-2) OR patients with a history of electrocardiogram (EKG) abnormalities, symptoms of cardiac ischemia, or arrhythmias
- Pulmonary
- Forced expiratory volume 1 (FEV\_1) ≥ 60% of predicted by pulmonary function test in patients with prolonged history of cigarette smoking or symptoms of respiratory dysfunction\*
- No active major respiratory illness
- No obstructive or restrictive pulmonary disease NOTE: \*For patients receiving high-dose IL-2 only
- Immunologic
- No active major immunologic illness
- No active systemic infections
- No primary or secondary immunodeficiency
- Fully recovered immune competence after prior chemotherapy or radiotherapy as evidenced by both of the following:
- Absolute neutrophil count \> 1,000/mm\^3
- No opportunistic infections
- Human Immunodeficiency virus (HIV) negative
- Epstein-Barr virus positive
- Other
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 4 months after study treatment
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- See Disease Characteristics
- Chemotherapy
- At least 6 weeks since prior nitrosourea therapy
- No prior cyclophosphamide and fludarabine as part of a preparative regimen on National Cancer Institute (NCI) Surgery Branch adoptive cell therapy studies unless sufficient numbers of CD34+ stem cells (more than 2 x10\^6/kg patient weight) have been obtained prior to the administration of chemotherapy
- Endocrine therapy
- No concurrent systemic steroid therapy
- Radiotherapy
- Not specified
- Surgery
- See Disease Characteristics
- Prior minor surgery within the past 3 weeks allowed if recovered
- Other
- Recovered from all prior therapy
- At least 30 days since prior systemic therapy
- No other concurrent experimental agents
Exclusion
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00096382
Start Date
September 1 2004
End Date
January 1 2009
Last Update
October 28 2015
Active Locations (2)
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1
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182
2
NCI - Surgery Branch
Bethesda, Maryland, United States, 20892-1201