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

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ClinicalTrials.gov Identifier: NCT00416871
Recruitment Status : Completed
First Posted : December 28, 2006
Last Update Posted : September 26, 2012
Sponsor:
Information provided by (Responsible Party):
Centre Leon Berard

Study Description
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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.


Condition or disease Intervention/treatment Phase
Kidney Cancer Biological: aldesleukin Biological: recombinant interferon alfa Phase 3

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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]
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00416871


Sponsors and Collaborators
Centre Leon Berard
Investigators
Study Chair: Sylvie Negrier, MD Centre Leon Berard
More Information
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Publications of Results:

Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT00416871     History of Changes
Other Study ID Numbers: CDR0000468028
LEONB-PERCY-DUO
LEONB-ET99-057
EU-20604
ROCHE-LEONB-PERCY-DUO
CHIRON-LEONB-PERCY-DUO
First Posted: December 28, 2006    Key Record Dates
Last Update Posted: September 26, 2012
Last Verified: September 2012

Keywords provided by Centre Leon Berard:
stage IV renal cell cancer
recurrent renal cell cancer

Additional relevant MeSH terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Aldesleukin
Interferons
Interferon-alpha
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-HIV Agents
Anti-Retroviral Agents