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Phase III Randomized Study of Intravenous Low Dose Versus Intravenous High Dose Versus Subcutaneous Interleukin-2 for Metastatic Renal Cell Carcinoma


Phase 3
18 Years
N/A
Not Enrolling
Both
Kidney Cancer

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Trial Information

Phase III Randomized Study of Intravenous Low Dose Versus Intravenous High Dose Versus Subcutaneous Interleukin-2 for Metastatic Renal Cell Carcinoma


OBJECTIVES: I. Determine the response rate and overall survival of patients with metastatic
renal cell carcinoma treated with either low-dose or high-dose intravenous interleukin-2
(IL-2) or subcutaneous IL-2. II. Compare the toxic effects of these 3 regimens in this
patient population.

OUTLINE: This is a randomized study. Patients are stratified according to presence of renal
tumor (yes vs no). Patients are randomized to one of three treatment arms. Arm I: Patients
receive low dose interleukin-2 (IL-2) IV every 8 hours for up to 15 doses. Treatment repeats
in 7-10 days for one complete course. Arm II: Patients receive high dose IL-2 IV every 8
hours for up to 15 doses. Treatment repeats in 7-10 days for one complete course. Arm III:
Patients receive IL-2 subcutaneously daily 5 days a week for 6 weeks. Treatment continues in
the absence of disease progression or unacceptable toxicity. Patients with stable or
responding disease receive an additional complete course of therapy.

PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven, metastatic renal cell carcinoma with
measurable disease No more than 25% of liver replaced with tumor No CNS involvement or
major nerve compression allowed

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
More than 3 months Hematopoietic: Not specified Hepatic: Bilirubin less than 2.0 mg/dL AST
and ALT no greater than 3 times normal Renal: Creatinine less than 1.6 mg/dL
Cardiovascular: Normal EKG Normal thallium stress test (required of patients 50 years of
age and older or as clinically indicated) Pulmonary: FEV1 and VC greater than 65% of
predicted (pulmonary function screening required of patients with significant smoking
history or suspicion of pulmonary disease) Other: No second malignancy, except: Basal cell
skin cancer Carcinoma in situ of the cervix No significant psychiatric disease that would
preclude consent or treatment No systemic infection No coagulation disorders or bleeding
Not pregnant HIV negative

PRIOR CONCURRENT THERAPY: No prior therapy within 28 days Biologic therapy: No prior
interleukin-2 Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy:
Not specified Surgery: Not specified Other: No concurrent steroids

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

James C. Yang, MD

Investigator Role:

Study Chair

Investigator Affiliation:

NCI - Surgery Branch

Authority:

United States: Federal Government

Study ID:

CDR0000076799

NCT ID:

NCT00018941

Start Date:

April 1991

Completion Date:

May 2003

Related Keywords:

  • Kidney Cancer
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

Surgery BranchBethesda, Maryland  20892