Interleukin-2 and Interferon in Treating Patients With Metastatic Kidney Cancer
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]
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- フェーズ 3
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- マスキング：なし（オープンラベル）
協力者と研究者
スポンサー
捜査官
- スタディチェア：Sylvie Negrier, MD、Centre Leon Berard
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- CDR0000468028
- LEONB-PERCY-DUO
- LEONB-ET99-057
- EU-20604
- ROCHE-LEONB-PERCY-DUO
- CHIRON-LEONB-PERCY-DUO
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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