Vaccine Therapy With or Without Interleukin-2 After Chemotherapy and an Autologous White Blood Cell Infusion in Treating Patients With Metastatic Melanoma
Stopped early · Phase 2
Conditions studied: Recurrent Melanoma, Stage IV Melanoma
In brief
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 metastatic melanoma. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy with interleukin-2, chemotherapy, and an autologous white blood cell infusion may be a more effective treatment for metastatic melanoma.
Key facts
- Study ID
- NCT00303836
- Run by
- National Cancer Institute (NCI)
- People needed
- 58
- Starts
- 2005-11-01
- Last updated by the study team
- 2013-06-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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%
Where it is running
- National Cancer Institute Surgery Branch — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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