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

Kidney Cancer Clinical Trial

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]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00416871
• Other study ID #: CDR0000468028
• Secondary ID: LEONB-PERCY-DUOL
• Status: Completed
• Phase: Phase 3
• First received: December 27, 2006
• Last updated: September 25, 2012
• Est. completion date: February 2006

Study information

• Verified date: September 2012
• Source: Centre Leon Berard
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Biological:
• aldesleukin

• recombinant interferon alfa

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Leon Berard

References & Publications (1)

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 m — View Citation