Leuvectin Followed By Surgery in Treating Patients With Stage II or Stage III Prostate Cancer
Phase II Study Evaluating the Safety and Efficacy of Neoadjuvant Leuvectin Immunotherapy for the Treatment of Prostate Cancer
RATIONALE: Inserting the gene for interleukin-2 into a person's cancer cells may improve the body's ability to fight cancer. Using Leuvectin to deliver this gene may be an effective treatment for prostate cancer.
PURPOSE: Phase II trial to study the effectiveness of Leuvectin followed by surgery in treating patients who have stage II or stage III prostate cancer.
調査の概要
詳細な説明
OBJECTIVES:
- Assess the toxicity and tolerability of neoadjuvant Leuvectin in patients with stage II or III prostate cancer.
- Evaluate the efficacy of this regimen in preventing or delaying manifestations of disease progression as demonstrated by biochemical failure or clinical recurrence in this patient population.
OUTLINE: This is a multicenter study.
Patients receive Leuvectin intraprostatically over 10-30 seconds under ultrasound guidance on day 0 followed by a second injection between days 4 and 7. Between days 8 and 14, patients undergo retropubic prostatectomy.
All patients are followed at 2 months. Patients with a PSA no greater than 0.2 ng/mL are followed at 4 months and 6 months, every 3 months for 12 months, and then every 6 months for 3.5 years in the absence of disease progression or biochemical failure.
ACTUAL ACCRUAL: 13 patients were accrued for this study.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
California
-
Los Angeles、California、アメリカ、90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
-
-
Ohio
-
Cleveland、Ohio、アメリカ、44195
- Cleveland Clinic Taussig Cancer Center
-
-
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 stage II or III organ confined prostate cancer
- Resectable disease (candidate for retropubic prostatectomy)
- Gleason score at least 6
- Prostate specific antigen value (PSA) at least 5 ng/mL
- No significant central nervous system (CNS) disease
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 80-100%
- Eastern Cooperative Oncology Group (ECOG) 0-1
Life expectancy
- Not specified
Hematopoietic
- White blood cell count (WBC) greater than 3,000/mm^3
- Platelet count greater than 100,000/mm^3
- Hemoglobin greater than 9.0 g/dL
Hepatic
- Bilirubin normal; serum glutamic oxaloacetic transaminase (SGOT), serum glutamic-pyruvic transaminase (SGPT) less than 3 times upper limit of normal
- Prothrombin time (PT)/partial thromboplastin time (PTT) normal
- Albumin greater than 3.0 g/dL
- Hepatitis B surface antigen negative
Renal
- Creatinine normal
Cardiovascular
- No uncontrolled hypertension
- No significant cardiovascular disease
- No history of ventricular dysfunction or arrhythmia
- No congestive heart failure
- No symptoms of coronary artery disease
- No prior myocardial infarction
Other
- No active autoimmune disease
- No active infection requiring parenteral antibiotics
- HIV negative
- No significant psychiatric disorder that would preclude compliance
- No other malignancy within the past 5 years except curatively treated basal or squamous cell skin cancer
- No diabetes mellitus
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy for prostate cancer
- At least 5 years since other prior chemotherapy
Endocrine therapy
- No prior glucocorticoids for prostate cancer
- At least 5 years since other prior glucocorticoids
Radiotherapy
- No prior radiotherapy for prostate cancer
- At least 5 years since other prior radiotherapy
Surgery
- See Disease Characteristics
- At least 4 weeks since prior intrathoracic or intrabdominal surgery
- At least 2 weeks since other major surgery
Other
- At least 10 days since prior anticoagulants or nonsteroidal antiinflammatory agents
- No other neoadjuvant or concurrent anticancer drugs
- No concurrent immunosuppressive drugs
- No other concurrent experimental therapy
- No concurrent parenteral antibiotics
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：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Leuvectin
2 intratumoral injections of 1000 ug of Leuvectin
|
Leuvectin injected intratumorally followed by prostatectomy
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Disease recurrence
時間枠：2 years
|
Measure timing and rate of disease recurrence
|
2 years
|
二次結果の測定
結果測定 |
|---|
|
ロイベクチンの安全性
|
協力者と研究者
スポンサー
捜査官
- スタディチェア：Arie Belldegrun, MD, FACS、Jonsson Comprehensive Cancer Center
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
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
- VCL-1102-202
- UCLA-9901077-03B (その他の識別子：UCLA)
- CDR0000067244 (レジストリ識別子：PDQ (Physician Data Query))
- NCI-G99-1568 (その他の識別子：NCI)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。