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

Léon Bérard Center

Status and phase: Completed; Phase 3

Conditions: Kidney Cancer

Treatments: Biological: recombinant interferon alfa; Biological: aldesleukin

Study type: Interventional

Funder types: Other

Identifiers

NCT00416871

ROCHE-LEONB-PERCY-DUO

CDR0000468028

LEONB-ET99-057

CHIRON-LEONB-PERCY-DUO

LEONB-PERCY-DUO

EU-20604

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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