---
title: Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
nct_id: NCT00018941
overall_status: COMPLETED
phase: PHASE3
sponsor: National Cancer Institute (NCI)
study_type: INTERVENTIONAL
primary_condition: Kidney Cancer
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00018941.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00018941"
ct_last_update_post_date: 2013-06-17
last_seen_at: "2026-05-12T07:06:47.914Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Interleukin-2 in Treating Patients With Metastatic Kidney Cancer

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

**NCT ID:** [NCT00018941](https://clinicaltrials.gov/study/NCT00018941)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Lead Sponsor:** National Cancer Institute (NCI)
- **Conditions:** Kidney Cancer
- **Start Date:** 1991-04
- **Completion Date:** 2003-05
- **CT.gov Last Update:** 2013-06-17

## Brief Summary

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. It is not yet known which regimen of interleukin-2 is most effective for kidney cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of interleukin-2 in treating patients who have metastatic kidney cancer.

## Detailed Description

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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Interventions

- **aldesleukin** (BIOLOGICAL)

## Locations (1)

- Surgery Branch, Bethesda, Maryland, United States

## Recent Field Changes (last 30 days)

- `design.phases` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.surgery branch|bethesda|maryland|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00018941.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00018941*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*