NCT00416871

Brief Summary

RATIONALE: Biological therapies, such as interleukin-2 and interferon, may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether interleukin-2 given by infusion is more effective than interleukin-2 given by injection when combined with interferon in treating metastatic kidney cancer. PURPOSE: This randomized phase III trial is studying interleukin-2 given by infusion to see how well it works compared to interleukin-2 given by injection when combined with interferon in treating patients with metastatic kidney cancer.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P25-P50 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 28, 2006

Completed
Last Updated

September 26, 2012

Status Verified

September 1, 2012

First QC Date

December 27, 2006

Last Update Submit

September 25, 2012

Conditions

Kidney Cancer

Keywords

stage IV renal cell cancerrecurrent renal cell cancer

Interventions

aldesleukinBIOLOGICAL
recombinant interferon alfaBIOLOGICAL

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic renal cell adenocarcinoma * More than one resectable metastatic site * No unresectable lesions after local curative treatment (i.e., radiotherapy) * In case of secondary lesions suspected on imaging (\< 1 cm and/or sparse lesions), metastatic disease must be confirmed by biopsy OR disease progression documented by imaging performed over several weeks * If patient has known prior metastatic lesions, progressive disease must have been confirmed within the past 3 months by noninvasive techniques * Nephrectomized * Measurable or evaluable disease * No brain metastases PATIENT CHARACTERISTICS: * Karnofsky performance status 90-100% * Hematocrit ≥ 30% * WBC ≥ 4,000/mm\^3 * Platelet count ≥ 120,000/mm\^3 * Bilirubin normal * Creatinine ≤ 1.7 mg/dL * FEV\_1 ≥ 50% * No severe cardiac dysfunction (i.e., grade III/IV heart disease), including any of the following: * Congestive heart failure * Coronary artery disease * Uncontrolled hypertension * Severe arrhythmia * No active infections requiring antibiotic treatment * No severe neuropsychiatric condition * No geographical, psychological, or familial conditions that would preclude study treatment * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * LVEF ≥ 50% * No severe autoimmune disease * No known chronic hepatitis * No HIV positivity * No hepatitis B surface antigen positivity * No prior or concurrent other cancer, except basal cell skin cancer or carcinoma in situ of the cervix * No severe pulmonary, hepatic, or renal condition that would preclude study treatment PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 6 weeks since prior wide-field radiotherapy * No prior allograft * No prior cytokines or chemotherapy * No concurrent corticosteroids

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (1)

  • Negrier S, Perol D, Ravaud A, Bay JO, Oudard S, Chabaud S, Fargeot P, Delva R, Deplanque G, Gravis G, Escudier B; French Immunotherapy Group. Randomized study of intravenous versus subcutaneous interleukin-2, and IFNalpha in patients with good prognosis metastatic renal cancer. Clin Cancer Res. 2008 Sep 15;14(18):5907-12. doi: 10.1158/1078-0432.CCR-08-0236.

    PMID: 18794104RESULT

MeSH Terms

Conditions

Kidney NeoplasmsCarcinoma, Renal Cell

Interventions

aldesleukinInterferon-alpha

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Interferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Sylvie Negrier, MD

    Centre Leon Berard

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2006

First Posted

December 28, 2006

Study Completion

February 1, 2006

Last Updated

September 26, 2012

Record last verified: 2012-09