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]
18 Years
70 Years
Both
Kidney Cancer
Trial Information
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]
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Sylvie Negrier, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Centre Leon Berard
Authority:
United States: Federal Government
Study ID:
CDR0000468028
NCT ID:
NCT00416871
Start Date:
Completion Date:
February 2006
Related Keywords:
- Kidney Cancer
- stage IV renal cell cancer
- recurrent renal cell cancer
- Carcinoma, Renal Cell
- Kidney Neoplasms
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