Interleukin-2 in Metastatic Melanoma

NCT ID: NCT01702896

Last Updated: 2018-04-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-12-31

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).

Conditions

Melanoma Metastatic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Interleukin-2

Interleukin-2 will be used in this group

Group Type: EXPERIMENTAL

Interleukin-2

Intervention Type: DRUG

Interleukin-2

Interventions

Interleukin-2

Interleukin-2

Intervention Type: DRUG

Other Intervention Names

IL2

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Western Regional Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jordan Waypa, FNP

Role: STUDY_DIRECTOR

Research Director

Locations

Western Regional Medical Center, Inc.

Goodyear, Arizona, United States

Countries

United States

Other Identifiers

12-07

Identifier Type: -

Identifier Source: org_study_id