Clinical trial · Interventional
Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer
Pilot Trial of Humanized Monoclonal Antibody J591 in Patients With Progressive Androgen-Independent Prostate Cancer
NCT00024232CI-TRIAL-00010745completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have prostate cancer that has not responded to hormone therapy.
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 |
|---|---|---|---|
| monoclonal antibody huJ591 | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed prostate cancer * Disease progression after prior castration * At least 3 rising PSA levels at least 1 week apart OR 2 rising levels at least 4 weeks apart * New osseous lesions on bone scan and/or more than 25% increase in bidimensionally measurable soft tissue disease or appearance of new sites of disease by CT scan or MRI * Testosterone no greater than 50 ng/mL * Medical therapy (e.g., gonadotropin-releasing hormone analogues) to maintain castrate level of testosterone should continue in the absence of surgical orchiectomy * Progression of disease after discontinuation of prior anti-androgen therapy * No requirement for palliative therapy within the past 12 weeks * No active CNS or epidural primary tumor OR active CNS or epidural metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * WBC greater than 3,500/mm3 * Platelet count greater than 100,000/mm3 Hepatic: * Bilirubin less than 1.5 mg/dL * Gamma-glutamyl-transferase less than upper limit of normal (ULN) * AST less than ULN * PT less than 14 seconds * No prior autoimmune hepatitis Renal: * Creatinine less than 1.5 mg/dL OR * Creatinine clearance greater than 60 mL/min Cardiovascular: * No clinically significant cardiac disease (New York Heart Association class III or IV) Pulmonary: * No severe debilitating pulmonary disease Other: * Fertile patients must use effective contraception * No active uncontrolled infection or infection requiring IV antibiotics * No prior autoimmune disease PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior murine protein for diagnostic or therapeutic purposes * No other concurrent anticancer immunotherapy Chemotherapy: * At least 4 weeks since prior chemotherapy and recovered * No concurrent anticancer chemotherapy Endocrine therapy: * See Disease Characteristics * No concurrent anticancer hormonal therapy Radiotherapy: * At least 4 weeks since prior radiotherapy and recovered * Concurrent radiotherapy to localized sites of disease (e.g., bone) allowed if the site does not contain sole measurable lesion Surgery: * See Disease Characteristics * No concurrent surgery Other: * Recovered from all prior therapy * At least 4 weeks since prior therapeutic investigational anticancer drugs * At least 4 weeks since prior participation in therapeutic clinical trial with an experimental drug * No prior diagnostic ProstaScint, Myoscint, or Oncoscint scans * No other concurrent therapeutic investigational anticancer agents * No concurrent participation in other therapeutic clinical trial with an experimental drug
References
Publications (0)
Data not yet available
No reference posted for this study.