Trial of Outpatient Intravenous Interleukin-2 in Malignant Melanoma and Metastatic Kidney Cancer

Melanoma Clinical Trial

Official title:

Phase II Trial of Outpatient Intravenous Interleukin-2 in Malignant Melanoma and Metastatic Kidney Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01355562
• Other study ID #: 5110062
• Status: Withdrawn
• Phase: Phase 2
• Start date: March 2011
• Est. completion date: February 2012

Study information

• Verified date: April 2020
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The current study will test single agent IL-2 in stage IV melanoma and kidney cancer.

Description:

The current study will test single agent IL-2 given daily for 4 doses every 3 weeks for a total of 12 doses in an outpatient setting in stage IV melanoma and kidney cancer to attempt to determine the response rate, how long the responses last, and median survival of this regimen in these two diseases. Responding patients and those with absence of disease progression may receive additional cycles of therapy every 3 weeks.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients must have a histologic diagnosis of metastatic kidney cancer or malignant melanoma Patients may be either newly diagnosed with metastatic disease or may have received prior treatment for metastatic kidney cancer.

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 < 2 x upper limit of normal; serum creatinine < 2.0 mg/dl.

5. Patients must undergo a low-level cardiac stress test (or similar cardiac evaluation such as dobutamine stress echocardiogram or radionuclide-based stress test) 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.

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

• Carcinoma, Renal Cell
• Kidney Neoplasms
• Melanoma
• Metastatic Kidney Cancer

Intervention

Drug:
• Interleukin-2 (IL-2)
Daily for 4 doses every 3 weeks for a total of 12 doses in an outpatient setting

Locations

Country	Name	City	State
United States	Highland Springs Medical Plaza	Beaumont	California
United States	Loma Linda University Cancer Center	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		9 weeks
Secondary	how long the tumor shrinkage lasts		9 weeks

External Links

•   Related Info