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

NCT ID: NCT00416871

Last Updated: 2012-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2006-02-28

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.

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.

Conditions

Kidney Cancer

Keywords

stage IV renal cell cancer; recurrent renal cell cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

aldesleukin

Intervention Type: BIOLOGICAL

recombinant interferon alfa

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Leon Berard

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sylvie Negrier, MD

Role: STUDY_CHAIR

Centre Leon Berard

References

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.

Reference Type: RESULT

PMID: 18794104 (View on PubMed)

Other Identifiers

LEONB-PERCY-DUO

Identifier Type: -

Identifier Source: secondary_id

LEONB-ET99-057

Identifier Type: -

Identifier Source: secondary_id

EU-20604

Identifier Type: -

Identifier Source: secondary_id

ROCHE-LEONB-PERCY-DUO

Identifier Type: -

Identifier Source: secondary_id

CHIRON-LEONB-PERCY-DUO

Identifier Type: -

Identifier Source: secondary_id

CDR0000468028

Identifier Type: -

Identifier Source: org_study_id