Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer
A Safety and Feasibility Study of Active Immunotherapy in Patients With Metastatic Prostate Carcinoma Using Autologous Dendritic Cells Pulsed With Antigen Encoded in Amplified Autologous Tumor RNA
NCT00010127CI-TRIAL-00009780terminatedPhase 1ClinicalTrials.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: Vaccines made from a person's cancer cells may make the body build an immune response to kill prostate tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic 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 |
|---|---|---|---|
| therapeutic autologous dendritic cells | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic adenocarcinoma of the prostate * Stage D1-3 * Regional lymph node, bone, visceral, or soft tissue metastases * No transitional cell or small cell carcinoma * Testosterone less than 50 mg/L if prior treatment with luteinizing hormone releasing hormone (LHRH) analogues or estrogens * Evidence of androgen refractory disease after surgical castration and discontinuation of LHRH analogue therapy * No previously irradiated or new CNS metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 70-100% Life expectancy: * More than 6 months Hematopoietic: * WBC at least 3,000/mm\^3 * Hemoglobin at least 9 g/dL * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin less than 2.0 mg/dL * PT at least 11.3 seconds but no greater than 13.3 seconds * PTT at least 20.1 seconds but no greater than 32.9 seconds * No hepatic disease * No viral hepatitis Renal: * Creatinine less than 2.5 mg/dL Cardiovascular: * No New York Heart Association class III or IV heart disease Pulmonary: * No asthma * No chronic obstructive pulmonary disease * No severe lung disease Other: * No other medical illness or psychological impediment that would preclude study * No other concurrent malignancy except nonmelanoma skin cancer or controlled superficial bladder cancer * No active acute or chronic infection including symptomatic urinary tract infection * No autoimmune disease (e.g., inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, scleroderma, or multiple sclerosis) * HIV negative * Adequate peripheral vein access PRIOR CONCURRENT THERAPY: Biologic therapy: * Prior biologic therapy allowed * No other concurrent immunotherapy Chemotherapy: * Prior chemotherapy allowed * No concurrent chemotherapy Endocrine therapy: * See Disease Characteristics * At least 4 weeks since prior non-steroidal hormonal therapy if increase in PSA while receiving non-steroidal hormonal therapy * At least 6 weeks since prior steroids * Concurrent LHRH analogues for gonadal androgen suppression allowed * No concurrent steroid therapy * No concurrent corticosteroids Radiotherapy: * See Disease Characteristics * Prior palliative radiotherapy for bone metastases allowed * Prior prostatic radiotherapy allowed * At least 4 weeks since prior radiotherapy * At least 12 weeks since prior strontium chloride Sr 89 * No concurrent radiotherapy Surgery: * See Disease Characteristics Other: * Recovered from prior therapy * No concurrent immunosuppressive agents (e.g., azathioprine or cyclosporine)
References
Publications (0)
Data not yet available
No reference posted for this study.