Aldesleukin in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer

Original Study ID : CDR0000473925

Secondary ID : Array

NCT ID : NCT00331617

Brief Title : Aldesleukin in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer

Official Title : Studies on the Mechanism of Action of High-Dose IL-2 in Metastatic Melanoma and Renal Cell Cancer

Brief Summary :

RATIONALE: Biological therapies, such as aldesleukin, may stimulate the white blood cells to kill tumor cells. Giving aldesleukin at high doses may kill more tumor cells. PURPOSE: This phase II trial is studying how well high-dose aldesleukin works in treating patients with metastatic melanoma or metastatic kidney cancer.

Source : National Cancer Institute (NCI)

Detailed Description :

OBJECTIVES: - Identify serum protein levels and lymphocyte phenotypes that may be associated with or predictive of tumor regression in patients with metastatic melanoma or metastatic renal cell cancer treated with high-dose aldesleukin. OUTLINE: This is a pilot study. Patients receive high-dose aldesleukin IV over 15 minutes 3 times daily for 4 days. Approximately 7-10 days later, patients receive additional aldesleukin as above 3 times daily for 4 days (course 1). Courses repeat every 2 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 245 patients will be accrued for this study.

Overall Status : Recruiting

Start Date : March 2006

Official Title : Phase 2

Phase : Interventional

Study Design : Treatment

Enrollment : 245

Verification Date : November 2008

First Received Date : May 30, 2006

Trial Eligibility

Criteria :
DISEASE CHARACTERISTICS:

- Histologically confirmed melanoma or renal cell cancer

- Metastatic disease

- No more than 25% estimated hepatic replacement by tumor

- Measurable disease

- Eligible for high-dose aldesleukin therapy

- No untreated or clinically significant (i.e., because of size or presence of edema)
tumor involvement of CNS or major nerve compression

PATIENT CHARACTERISTICS:

- Life expectancy > 3 months

- ECOG performance status 0-1

- Creatinine ≤ 1.4 mg/dL

- Bilirubin ≤ 2.0 mg/dL (< 3.0 mg/dL for Gilbert's syndrome)

- Platelet count > 100,000/mm^3

- Absolute neutrophil count > 1,000/mm^3

- ALT and AST < 3 times upper limit of normal

- No significant second malignancy within the past 3 years or that would likely require
intervention within 1 year of study entry

- No significant psychiatric disease that would preclude study treatment

- No systemic infections, coagulation disorders or evidence of active bleeding, or other
major medical illnesses of the cardiovascular, respiratory, or immune system

- Not pregnant

- Fertile patients must use effective contraception

- No HIV positivity

- No hepatitis B or C positivity

- FEV_1 or vital capacity > 65% of predicted

- Patients with a significant smoking history (> 20 pk/years) or suspicion of
pulmonary disease must undergo pulmonary function screening

- LVEF ≥ 45%

- Must be determined in all patients ≥ 60 years old and others as clinically
indicated

- No active cardiac ischemia or significantly abnormal EKG

PRIOR CONCURRENT THERAPY:

- At least 28 days since prior therapy except focal radiation for bone lesion

- No prior aldesleukin therapy

- No concurrent systemic or inhaled steroids

- Concurrent topical steroid therapy allowed

Gender : Both

Minimum Age : 18 Years

Maximum Age : N/A

Healthy Volunteers : No

Facilities

Facility Name : Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Status : Recruiting

City : Bethesda

State : Maryland

Zip Code : 20892-1182

Country : United States

OutComes

Primary OutComes

Measure : Clinical outcome as measured by RECIST

Safety issue : No

Interventions

Type : Biological

Name : aldesleukin

Clinical Trial Name - Aldesleukin in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer