Status:
TERMINATED
Vaccine Therapy With or Without Interleukin-2 After Chemotherapy and an Autologous White Blood Cell Infusion in Treating Patients With Metastatic Melanoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Recurrent Melanoma
Stage IV Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This randomized phase II trial is studying how well giving vaccine therapy with or without interleukin-2 after chemotherapy and an autologous white blood cell infusion works in treating patients with ...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the ability of gp100 and MART-1 peptide vaccines with or without a high-dose interleukin-2 (IL-2), when administered after a nonmyeloablative, lymphodepleting prepara...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Diagnosis of metastatic melanoma
- No tumor reactive cells available for cell transfer therapy
- Measurable disease
- Previously treated with interleukin-2 (IL-2) and meets 1 of the following criteria:
- No response (progressive disease)
- Recurrent disease
- HLA\*0201 positive
- ECOG performance status 0 or 1
- Absolute neutrophil count \> 1,000/mm\^3
- Platelet count \> 100,000/mm\^3
- Hemoglobin \> 8.0 g/dL
- ALT and AST \< 3 times upper limit of normal
- Bilirubin ≤ 2.0 mg/dL (\< 3.0 mg/dL if Gilbert's disease is present)
- Creatinine ≤ 2.0 mg/dL
- Life expectancy ≥ 3 months
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for up to 4 months after receiving the preparative regimen
- No active systemic infections, coagulation disorders, or other major medical illnesses of the cardiovascular, respiratory, or immune system, as evidenced by a positive stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, or obstructive or restrictive pulmonary disease
- No autoimmune disease (e.g., autoimmune colitis or Crohn's disease) or primary immunodeficiency disease
- No HIV positivity
- No hepatitis B or C virus positivity
- No Epstein-Barr virus negativity
- Eligible to receive high-dose IL-2, as evidenced by the following:
- Patients ≥ 50 years of age must have a normal cardiac stress test (e.g., stress thallium, stress MUGA, dobutamine echocardiogram, or other stress test) AND LVEF ≥ 45%
- Patients with a history of EKG abnormalities, symptoms of cardiac ischemia, or arrhythmias must have a normal cardiac stress test AND LVEF ≥ 45%
- Patients with a prolonged history of cigarette smoking or symptoms of respiratory dysfunction must have a normal pulmonary function test, as evidenced by FEV 1 ≥ 60% of predicted
- At least 4 weeks since prior systemic therapy
- At least 6 weeks since prior nitrosourea therapy
- No concurrent systemic steroid therapy
- Recovered immune competence after prior chemotherapy or radiotherapy
- No prior gp100:209-217 or MART-1:27-35 peptide vaccine
Exclusion
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00303836
Start Date
November 1 2005
Last Update
June 6 2013
Active Locations (1)
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1
National Cancer Institute Surgery Branch
Bethesda, Maryland, United States, 20892-1201