Trial | NCT00003126  Report issue

Title

Interleukin-2 in Treating Patients With Stage III or Stage IV Kidney Cancer
A Randomized Controlled Phase III Adjuvant Trial of High-Dose Bolus IL-2 in Patients With High-Risk Renal Cell Carcinoma

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    69
The purpose of this study is to assess the efficacy of post-operative high-dose bolus interleukin-2 (IL-2) in patients with high-risk renal cell carcinoma (RCC).
The primary objective of this prospective, randomized, controlled trial is to compare the disease-free and overall survival of patients with stage III or IV high-risk renal cell carcinoma (RCC) who were treated with adjuvant high-dose interleukin-2 vs observation alone.

Patients are stratified according to their disease classification and randomized to one course of IL-2 [600,000 U/kg every 8 hours on days 1 to 5 and days 15 to 19 (maximum 28 doses)] or observation.
Study Started
Jun 30
1997
Primary Completion
Aug 31
2002
Study Completion
Aug 31
2002
Last Update
Jan 04
2017
Estimate

Drug Interleukin-2

High-dose bolus interleukin-2 is a systemic therapy used to treat metastatic RCC

  • Other names: IL-2, Aldesleukin

Interleukin-2 (IL-2) Experimental

Patients randomized to this arm will receive one course of IL-2 [600,000 U/kg every 8 hours on post-operative days 1 to 5 and days 15 to 19 (maximum 28 doses)].

Observation No Intervention

Patients randomized to this arm will receive their normal medical care

Criteria 

Inclusion Criteria

An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Adequate organ function as defined by a white blood cell (WBC) count of 4,000/L; a platelet count of 100,000/L; a Hemoglobin level of 10 g/dL; a serum creatinine of 1.5 mg/dL or creatinine clearance of 60 mL/min; and a direct bilirubin level of 1.5 mg/dL.
Forced expiratory volume at 1 second more than 2.0 L or 75% of predicted for height and age from pre-enrollment pulmonary function testing.
No history or evidence of cardiac disease on ECG
No prior systemic treatment for RCC, but patients may have received prior locoregional radiation therapy to solitary resectable metastases, which must have undergone surgical resection before enrollment.
No prior history of invasive malignancy in the past 5 years
Human immunodeficiency virus (HIV) negative
Female patients must not be pregnant or planning to become pregnant

Exclusion criteria

• Age younger than 16
No Results Posted