Interleukin-2 in Treating Patients With Stage III or Stage IV Kidney Cancer

Loyola University

Status and phase: Completed; Phase 3

Conditions: Kidney Cancer

Treatments: Drug: Interleukin-2

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00003126

852006

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 69 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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69 participants in 2 patient groups

Interleukin-2 (IL-2)

Experimental group

Description:

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

Treatment:

Drug: Interleukin-2

Observation

No Intervention group

Description:

Patients randomized to this arm will receive their normal medical care