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

Completed · Phase 2

Conditions studied: Melanoma (Skin)

In brief

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.

Key facts

Study ID

NCT00085423

Run by

Dartmouth-Hitchcock Medical Center

People needed

20

Starts

2004-02-01

Expected to finish

2010-02-01

Last updated by the study team

2013-04-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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

Where it is running

• Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States

Full record on ClinicalTrials.gov

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