Status:
TERMINATED
Laboratory-Treated Autologous Lymphocytes and Aldesleukin After Cyclophosphamide and Fludarabine in Treating Patients With Metastatic Melanoma
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Treating lymphocytes in the laboratory may help the lymphocytes kill more tumor cells when they are put back in the body. Aldesleukin may stimulate the lymphocytes to kill tumor cells. Drug...
Detailed Description
OBJECTIVES: Primary * Determine the ability of treatment with short-term cultured autologous tumor-infiltrating lymphocytes (TIL) in combination with high-dose aldesleukin after a nonmyeloablative l...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of metastatic melanoma
- Refractory to standard treatment including high-dose aldesleukin (IL-2), unless previously ineligible for or refused IL-2
- Measurable disease with ≥ 1 lesion that is resectable for tumor-infiltrating lymphocyte generation
- Patients with ≥ 1 brain metastases \< 1 cm each, or 1-2 brain metastases \> 1 cm are eligible provided they have been treated and stable for ≥ 3 months
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy \> 3 months
- ANC \> 1,000/mm\^3 (without filgrastim support)
- WBC \> 3,000/mm\^3
- Hemoglobin \> 8.0 g/dL
- Platelet count \> 100,000/mm\^3
- Serum ALT/AST \< 3 times upper limit of normal
- Total bilirubin ≤ 2 mg/dL (\< 3 mg/dL in patients with Gilbert's syndrome)
- Serum creatinine ≤ 1.6 mg/dL
- LVEF \> 45% in patients meeting the following criteria:
- Clinically significant atrial and/or ventricular arrhythmias, including, but not limited to, atrial fibrillation, ventricular tachycardia, or second- or third-degree heart block
- At least 60 years of age
- FEV\_1 \> 60% in patients meeting the following criteria:
- Prolonged history of cigarette smoking
- Symptoms of respiratory dysfunction
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 4 months after completion of study treatment
- No HIV or hepatitis B or C positivity
- No form of primary immunodeficiency (e.g., severe combined immunodeficiency disease or AIDS)
- No opportunistic infections
- No active systemic infections
- No history of severe immediate hypersensitivity reaction to any of the agents used in this study
- No coagulation disorders
- No myocardial infarction, cardiac arrhythmias, or positive stress thallium or comparable test
- No history of coronary revascularization or ischemic symptoms
- No obstructive or restrictive pulmonary disease
- No other active major medical illness of the cardiovascular, respiratory, or immune system
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from prior therapy (alopecia or vitiligo allowed)
- At least 6 weeks since prior ipilimumab
- Must have normal colonoscopy with normal colonic biopsies
- At least 4 weeks since prior systemic therapy
- Minor surgical procedures within the past 3 weeks allowed provided all toxicities have recovered to ≤ grade 1
- No concurrent systemic steroids
- No other concurrent experimental agents
Exclusion
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00863330
Start Date
February 1 2009
End Date
July 1 2012
Last Update
October 3 2024
Active Locations (1)
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1
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215