Interleukin-2 in Metastatic Melanoma

Melanoma Metastatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01702896
• Other study ID #: 12-07
• Status: Terminated
• Phase: Phase 2
• First received: October 4, 2012
• Last updated: April 3, 2018
• Start date: September 2012
• Est. completion date: December 2014

Study information

• Verified date: April 2018
• Source: Western Regional Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma
• Melanoma Metastatic

Intervention

Drug:
• Interleukin-2
Interleukin-2

Locations

Country	Name	City	State
United States	Western Regional Medical Center, Inc.	Goodyear	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Western Regional Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate	Radiographic studies to evaluate for response were done after every 2 cycles (6 weeks) until disease progression or death from any cause up to 2 years. Standard RECIST response criteria were utilized. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = 100%(CR + PR/total number of patients receiving Interleukin-2).	Measured until Disease Progression or death from any cause up to 2 years
Secondary	Median Duration of Response	Duration of response is calculated as the time (months) from the date at which response is first observed (per standard Response Evaluation Criteria In Solid Tumors [RECIST] to the date of first observed disease progression or date of death from any cause, whichever came first, assessed up to 2 years. The actual date of tumor assessments was used for this calculation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new lesions.	Measured until Disease Progression or death from any cause up to 2 years
Secondary	Median Survival	Measured from date of entry on study until date of death	From time of study entry until death, up to 10 years