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.
Studienübersicht
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
-
-
California
-
Los Angeles, California, Vereinigte Staaten, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
-
-
Ohio
-
Cleveland, Ohio, Vereinigte Staaten, 44195
- Cleveland Clinic Taussig Cancer Center
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Leuvectin
2 intratumoral injections of 1000 ug of Leuvectin
|
Leuvectin injected intratumorally followed by prostatectomy
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Disease recurrence
Zeitfenster: 2 years
|
Measure timing and rate of disease recurrence
|
2 years
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
|---|
|
Sicherheit von Leuvektin
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienstuhl: Arie Belldegrun, MD, FACS, Jonsson Comprehensive Cancer Center
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Neubildungen
- Urogenitale Neoplasmen
- Neubildungen nach Standort
- Genitale Neubildungen, männlich
- Prostataerkrankungen
- Prostataneoplasmen
- Physiologische Wirkungen von Arzneimitteln
- Agenten des peripheren Nervensystems
- Analgetika
- Agenten des sensorischen Systems
- Analgetika, nicht narkotisch
- Antineoplastische Mittel
- Interleukin-2
Andere Studien-ID-Nummern
- VCL-1102-202
- UCLA-9901077-03B (Andere Kennung: UCLA)
- CDR0000067244 (Registrierungskennung: PDQ (Physician Data Query))
- NCI-G99-1568 (Andere Kennung: NCI)
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