Clinical trial NCT01702896: Interleukin-2 in Metastatic Melanoma
Official title: Phase II Trial of Moderate Dose Bolus Interleukin-2 in Metastatic Melanoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Melanoma Metastatic
Keywords: Metastatic Melanoma
Lead sponsor: Western Regional Medical Center
Sponsor class: OTHER
First posted: 2012-10-10
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine whether Interleukin-2 at the dose and schedule will help to increase tumor shrinkage

Detailed description: 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).

Eligibility criteria: 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 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 excluded.
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 accident.
6. Current brain metastasis.

Primary outcomes:
measure: Response Rate
timeFrame: Measured until Disease Progression or death from any cause up to 2 years
Secondary outcomes:
measure: Median Duration of Response
timeFrame: Measured until Disease Progression or death from any cause up to 2 years
measure: Median Survival
timeFrame: From time of study entry until death, up to 10 years
Other outcomes:
Locations:
city: Goodyear
country: United States
facility: Western Regional Medical Center, Inc.
state: Arizona
Study officials:
affiliation: Research Director
name: Jordan Waypa, FNP
role: STUDY_DIRECTOR
References: