Clinical trial · Interventional
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
NCT00004050CI-TRIAL-00015235terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Development in prostate cancer indication halted
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Leuvectin | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Leuvectin
- description
- 2 intratumoral injections of 1000 ug of Leuvectin
- interventionNames
- Biological: Leuvectin
Primary outcomes (1)
- measure
- Disease recurrence
- timeFrame
- 2 years
- description
- Measure timing and rate of disease recurrence
Secondary outcomes (1)
- measure
- Safety of Leuvectin
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.