Cyclophosphamide, Fludarabine, and High-Dose Interleukin-2 in Treating Patients With Metastatic Melanoma

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

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. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells and may help a person's immune system recover from the side effects of chemotherapy.

PURPOSE: This phase II trial is studying how well giving cyclophosphamide and fludarabine together with high-dose interleukin-2 works in treating patients with metastatic melanoma.

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

Details

• Lead Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Aldesleukin; Cyclophosphamide; Fludarabine; Fludarabine phosphate; Interleukin-2; Molgramostim; Sargramostim; Vidarabine

Criteria

Inclusion Criteria:

• Histologically confirmed melanoma

• Metastatic disease

• Measurable disease

• No history of brain metastases

• Over 18

• Karnofsky 60-100%

• Life expectancy At least 12 weeks

• Hematopoietic

• Absolute neutrophil count ≥ 1,000/mm^3

• Platelet count ≥ 75,000/mm^3

• Hemoglobin ≥ 8.5 g/dL

• aspartate aminotransferase ≤ 2 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)

• Bilirubin ≤ 2 times ULN (except for patients with Gilbert's syndrome)

• Hepatitis B and C negative

• Creatinine ≤ 2.0 times ULN

• Creatinine clearance ≥ 50 mL/min

• Cardiovascular

• Ejection fraction ≥ 50%

• No evidence of congestive heart failure

• No symptoms of coronary artery disease

• No serious cardiac arrhythmias

• No myocardial infarction within the past 6 months

• Cardiac stress test negative or of low probability for patients > 40 years of age OR who have had prior myocardial infarction > 6 months ago

• Pulmonary Forced expiratory volume 1 ≥ 2.0 liters OR at least 75% of predicted for height and age

• Diffusing capacity of lung for carbon monoxide ≥ 60%

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• HIV negative

Exclusion Criteria:

• No uncontrolled diabetes

• No history of autoimmune disease

• No active infection

• No other concurrent significant illness that would preclude study participation

• No other malignancy within the past 5 years except nonmelanoma skin cancer or non-invasive cancer (e.g., carcinoma in situ of the cervix, superficial bladder cancer without local recurrence, or carcinoma in situ of the breast)

• At least 4 weeks since prior immunotherapy and recovered

• No other concurrent anticancer biologic agents

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

• No concurrent chemotherapy

• At least 4 weeks since prior steroid therapy

• No concurrent corticosteroids

• At least 4 weeks since prior radiotherapy and recovered

• No concurrent radiotherapy

• At least 4 weeks since prior surgery and recovered

• No concurrent immunosuppressive therapy