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CompletedNCT00416871Updated Sep 26, 2012

Interleukin-2 and Interferon in Treating Patients With Metastatic Kidney Cancer

A Phase 3 interventional study of aldesleukin and recombinant interferon alfa in Kidney Cancer, sponsored by Centre Leon Berard. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-09-26.

Sponsored by Centre Leon Berard · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed description

OBJECTIVES:

Primary

  • Compare the overall survival of patients with metastatic renal cell cancer treated with intravenous vs subcutaneous interleukin-2 in combination with interferon alfa.

Secondary

  • Compare progression-free survival of patients treated with these regimens.
  • Compare response rates (complete and partial) in patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.
  • Compare quality of life of patients treated with these regimens.

OUTLINE: This is an open-label, randomized, parallel-group, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive induction therapy comprising interleukin-2 (IL-2) IV continuously over days 1-5, 15-19, 43-47, and 57-61 (weeks 1, 3, 7, and 9) and interferon alfa (IFN-α) subcutaneously (SC) three times weekly in weeks 1-3 and 7-9. Patients then undergo restaging. Patients achieving a complete response (CR), partial response (PR), or stable disease (SD) then receive maintenance therapy comprising IL-2 IV continuously over 5 days and IFN-α SC three times weekly in weeks 1, 5, 9, and 13.
  • Arm II: Patients receive induction therapy comprising IL-2 SC twice daily on days 1-5, 8-12, 15-19, and 22-26 (weeks 1-4). Patients also receive IFN-α SC three times weekly in weeks 1-4 and 6-9. Patients then undergo restaging. Patients achieving a CR, PR, or SD then receive maintenance therapy comprising IL-2 SC as in induction therapy and IFN-α SC three times weekly in weeks 1-4 and 8-11.

Quality of life is assessed at baseline, at the end of induction therapy, and then at the end of maintenance therapy.

After completion of treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 220 patients will be accrued for this study.

02

Conditions studied

  • Kidney Cancer

Keywords

  • stage IV renal cell cancer
  • recurrent renal cell cancer
03

In context

Kidney Neoplasms

956 studies on the registry are indexed under Kidney Neoplasms; 210 are open to participants now.

This study's planned enrollment of 220 is above the median of 43 across 650 interventional studies indexed under Kidney Neoplasms.

Browse Kidney Neoplasms studies →

Lead sponsor

Centre Leon Berard is the lead sponsor of 206 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Masking
None (open label)
Enrollment
220 participants (estimated)

Interventions

  • Biologicalaldesleukin
  • Biologicalrecombinant interferon alfa
06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 18794104 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00416871
Lead sponsor
Centre Leon Berard
Responsible party
Sponsor
First posted
Dec 28, 2006
Completion
Feb 2006
Last update
Sep 26, 2012

Study contacts

Sylvie Negrier, MD
study chair · Centre Leon Berard
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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