Interleukin-2 and Interferon in Treating Patients With Metastatic Kidney Cancer
This study has been completed.
Sponsor:
Centre Leon Berard
Information provided by (Responsible Party):
Centre Leon Berard
ClinicalTrials.gov Identifier:
NCT00416871
First received: December 27, 2006
Last updated: September 25, 2012
Last verified: September 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Kidney Cancer |
Biological: aldesleukin Biological: recombinant interferon alfa |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: 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] |
Resource links provided by NLM:
Further study details as provided by Centre Leon Berard:
| Estimated Enrollment: | 220 |
| Study Completion Date: | February 2006 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| 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 More Information
Additional Information:
Publications:
| 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 |
| Study First Received: | December 27, 2006 |
| Last Updated: | September 25, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Centre Leon Berard:
|
stage IV renal cell cancer recurrent renal cell cancer |
Additional relevant MeSH terms:
|
Carcinoma, Renal Cell Kidney Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Interferon-alpha Interferon Alfa-2a Interferons |
Aldesleukin Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Anti-HIV Agents Anti-Retroviral Agents |
ClinicalTrials.gov processed this record on May 16, 2013