Trials / Completed
CompletedNCT00003126
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 69 (actual)
- Sponsor
- Loyola University · Academic / Other
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Not accepted
Summary
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).
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Interleukin-2 | High-dose bolus interleukin-2 is a systemic therapy used to treat metastatic RCC |
Timeline
- Start date
- 1997-06-01
- Primary completion
- 2002-08-01
- Completion
- 2002-08-01
- First posted
- 2003-10-28
- Last updated
- 2017-01-04
Locations
15 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00003126. Inclusion in this directory is not an endorsement.