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

L

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)

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

Trial contacts and locations

15

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Data sourced from clinicaltrials.gov

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