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Phase 2 Trial of T-cell Based Low-dose Cyclophosphamide and Outpatient Intravenous Interleukin-2 in Metastatic Melanoma

Phase 2
18 Years
Open (Enrolling)
Metastatic Melanoma

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Trial Information

Phase 2 Trial of T-cell Based Low-dose Cyclophosphamide and Outpatient Intravenous Interleukin-2 in Metastatic Melanoma

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.

Inclusion Criteria:

1. Patients must have a histologic diagnosis of metastatic melanoma. Patients may have
received prior systemic therapy or may be previously untreated.

2. Patients must have measurable disease on physical exam or radiologic studies.

3. ECOG performance status of 0 or 1 and estimated survival of at least 3 months.

4. 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.

5. 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.

6. Patients with elevated temperatures > 100.5 F must have sources of occult infection

7. Patients must be felt to have recovered from effects of prior therapy, such as > 2
weeks after prior chemotherapy.

8. Women of childbearing potential must have a negative pregnancy test and adequate
precautions to prevent pregnancy during treatment must be taken.

9. Patient consent must be obtained prior to entrance onto study.

Exclusion Criteria:

- 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

6. Current untreated brain metastasis.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate

Outcome Time Frame:

One year

Safety Issue:


Principal Investigator

Walter Quan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Western Regional Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

October 2012

Completion Date:

October 2013

Related Keywords:

  • Metastatic Melanoma
  • Melanoma



Western Regional Medical Center Inc Goodyear, Arizona  85338