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Phase II Trial of Moderate Dose Bolus Interleukin-2 in Metastatic Melanoma

Phase 2
18 Years
Open (Enrolling)
Melanoma Metastatic

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Trial Information

Phase II Trial of Moderate Dose Bolus Interleukin-2 in Metastatic Melanoma

In this phase II trial, the previously described IL-2 schedule (daily IL-2 for 5 days (per
week) every 3 weeks) will be tested in a larger cohort of patients with melanoma to attempt
to determine the response rate, median duration of response, and median survival. The dose
intensity of this schedule would allow a patient treated on this regimen to achieve the
target threshold (> 1440 million IU/m2/year).

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 bi-dimensional measurable disease on physical exam or radiologic

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

9. Women of childbearing potential must have a negative pregnancy test and must take
adequate precautions to prevent pregnancy during treatment

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 brain metastasis.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival of patients with metastatic melanoma who have had disease progression on at least one prior systemic therapy or has not been treated

Outcome Time Frame:

9 weeks

Safety Issue:


Principal Investigator

Walter Quan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Western Regional Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

September 2012

Completion Date:

December 2013

Related Keywords:

  • Melanoma Metastatic
  • Metastatic Melanoma
  • Melanoma



Western Regional Medical Center, Inc.Goodyear, Arizona  85338