Status:
WITHDRAWN
Low-dose Cyclophosphamide and Outpatient IV Interleukin-2 in Metastatic Melanoma
Lead Sponsor:
Western Regional Medical Center
Conditions:
Metastatic Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
To determine the response rate, median duration of response and median survival of patients treated with this low-dose cyclophosphamide + moderate dose bolus Interleukin-2 schedule.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 1\. Medical illness requiring corticosteroids or other immunosuppressive agents (such as cyclosporin or methotrexate.
- 2\. Autoimmune disease such as inflammatory arthritis which could be exacerbated by immune-based therapy.
- 3\. Prior history of psychiatric disorder which could be exacerbated by interleukin-2.
- 4\. Lactation or pregnancy.
- 5\. 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.
- 6\. Current untreated brain metastasis.
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01833767
Start Date
October 1 2012
End Date
December 1 2015
Last Update
August 24 2017
Active Locations (1)
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1
Western Regional Medical Center Inc
Goodyear, Arizona, United States, 85338