Vaccine Therapy With or Without Interleukin-2 After Chemotherapy and an Autologous White Blood Cell Infusion in Treating Patients With Metastatic Melanoma

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Aldesleukin; Cyclophosphamide; Fludarabine; Fludarabine phosphate; Freund's Adjuvant; Interleukin-2; Lenograstim

Criteria

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