Low-dose Cyclophosphamide and Outpatient IV Interleukin-2 in Metastatic Melanoma
Verified January 2014 by Western Regional Medical Center
Information provided by (Responsible Party):
Walter Quan Jr., MD, Western Regional Medical Center
First received: April 14, 2013
Last updated: January 9, 2014
Last verified: January 2014
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.
Drug: Cyclophosphamide and Interleukin 2
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase 2 Trial of T-cell Based Low-dose Cyclophosphamide and Outpatient Intravenous Interleukin-2 in Metastatic Melanoma
Primary Outcome Measures:
- Response Rate [ Time Frame: One year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Median Survival [ Time Frame: One year ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2015 (Final data collection date for primary outcome measure)
Experimental: Cyclophosphamide and Interleukin-2
Cytoxan IV on day 1, IL2 IV on days 1-5
Drug: Cyclophosphamide and Interleukin 2
Cytoxan IV day 1, IL2 IV days 1-5
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
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.
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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01833767
|Western Regional Medical Center Inc
|Goodyear, Arizona, United States, 85338 |
|Principal Investigator: Walter Quan, MD |
Western Regional Medical Center
||Walter Quan, MD
||Western Regional Medical Center
No publications provided
||Walter Quan Jr., MD, Cheif of Medical Oncology, Western Regional Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 14, 2013
||January 9, 2014
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 03, 2015
Antineoplastic Agents, Alkylating
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents