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

Primary Purpose

Kidney Cancer

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

aldesleukin

recombinant interferon alfa

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring stage IV renal cell cancer, recurrent renal cell cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00416871

First Posted

December 27, 2006

Last Updated

September 25, 2012

Sponsor

Centre Leon Berard

1. Study Identification

Unique Protocol Identification Number

NCT00416871

Brief Title

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

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]

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Completed

Study Start Date

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Primary Completion Date

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Study Completion Date

February 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Leon Berard

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Cancer

Keywords

stage IV renal cell cancer, recurrent renal cell cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Masking

None (Open Label)

Allocation

Randomized

Enrollment

220 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

aldesleukin

Intervention Type

Biological

Intervention Name(s)

recombinant interferon alfa

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sylvie Negrier, MD

Organizational Affiliation

Centre Leon Berard

Official's Role

Study Chair

12. IPD Sharing Statement

Citations:

PubMed Identifier

18794104

Citation

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.

Results Reference

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

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