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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Leon Berard
ClinicalTrials.gov Identifier:
NCT00416871
First received: December 27, 2006
Last updated: September 25, 2012
Last verified: September 2012

December 27, 2006
September 25, 2012
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Complete list of historical versions of study NCT00416871 on ClinicalTrials.gov Archive Site
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Interleukin-2 and Interferon in Treating Patients With Metastatic Kidney Cancer
Cytokines in the Treatment of Metastatic Renal Cell Carcinoma (MRCC): Intravenous Interleukin and Subcutaneous Interferon-α Versus Subcutaneous Interleukin and Interferon-α for Good Prognosis Patients [PERCY DUO]

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.

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.

Interventional
Phase 3
Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Kidney Cancer
  • Biological: aldesleukin
  • Biological: recombinant interferon alfa
Not Provided
Négrier 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
February 2006
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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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00416871
CDR0000468028, LEONB-PERCY-DUO, LEONB-ET99-057, EU-20604, ROCHE-LEONB-PERCY-DUO, CHIRON-LEONB-PERCY-DUO
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Centre Leon Berard
Centre Leon Berard
Not Provided
Study Chair: Sylvie Negrier, MD Centre Leon Berard
Centre Leon Berard
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP