Low-dose Cyclophosphamide and Outpatient IV Interleukin-2 in Metastatic Melanoma

Withdrawn before enrolling · Phase 2

Conditions studied: Metastatic Melanoma

In brief

The purpose of this study is to determine response rates by administering low dose cyclophosphamide on day 1, followed by 5 days of outpatient IL2.

Key facts

Study ID

NCT01833767

Run by

Western Regional Medical Center

People needed

0

Starts

2012-10-01

Expected to finish

2015-12-01

Last updated by the study team

2017-08-24

Who can join

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

You may qualify if…

• Patients must have a histologic diagnosis of metastatic melanoma. Patients may have received prior systemic therapy or may be previously untreated.
• Patients must have measurable disease on physical exam or radiologic studies.
• ECOG performance status of 0 or 1 and estimated survival of at least 3 months.
• White blood count of > 3500/mm3, platelet count > 100,000/mm3, hemoglobin > 9.0 gm/dl; bilirubin, ALT, AST < 3 x upper limit of normal; serum creatinine < 2.0 mg/dl.
• Patients must undergo a low-level cardiac stress test as a screen for possible atherosclerotic heart disease. Patients with a positive stress test would be excluded from this trial.
• Patients with elevated temperatures > 100.5 F must have sources of occult infection excluded.
• Patients must be felt to have recovered from effects of prior therapy, such as > 2 weeks after prior chemotherapy.
• Women of childbearing potential must have a negative pregnancy test and adequate precautions to prevent pregnancy during treatment must be taken.
• Patient consent must be obtained prior to entrance onto study.

You may not qualify if…

• 1. Medical illness requiring corticosteroids or other immunosuppressive agents (such as cyclosporin or methotrexate.
• Autoimmune disease such as inflammatory arthritis which could be exacerbated by immune-based therapy.
• Prior history of psychiatric disorder which could be exacerbated by interleukin-2.
• Lactation or pregnancy.
• Evidence of significant cardiovascular disease including history of recent (< 6 months prior) myocardial infarction, congestive heart failure, primary cardiac arrhythmias (not due to electrolyte disorder or drug toxicity, for example) beyond occasional PVC's, angina, positive low-level stress test, or cerebrovascular accident.
• Current untreated brain metastasis.

Where it is running

• Western Regional Medical Center Inc — Goodyear, Arizona, United States

Full record on ClinicalTrials.gov

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