Clinical trial · Interventional
Study of a Drug [DCVax (tm)-Prostate] to Treat Prostate Cancer When Hormone Therapy is no Longer Effective.
A Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial Evaluating DCVax(tm)-Prostate, Autologous Dendritic Cells Loaded With Recombinant PSMA for the Treatment of Metastatic Hormone Refractory Prostate Cancer
NCT00043212CI-TRIAL-00010183withdrawnPhase 3ClinicalTrials.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): Redirection of company goals
Summary
Brief summary (as posted)
The purpose of this clinical research study is to assess the safety and efficacy of an investigational therapy called DCVax(TM)-Prostate.
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 |
|---|---|---|---|
| Dendritic cell immunotherapy | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Hormone refractory prostate cancer (HRPC) \– progressive disease despite androgen deprivation and serum testosterone \<50ng/dL; progression defined as either: 1. Rising PSA over 6 months with at least a 50% increase between the 1st and 3rd measurement, and the 3rd measurement \>2.0 ng/ml; or 2. Progression of metastatic lesion on bone scan, or 3. Progression of lymph node metastasis by CT scan. * Zubrod or ECOG performance status of 0-1. * Three or fewer bone metastases on a bone scan with minimal symptoms. * No lymph node lesions greater than 3.0 cm at longest diameter. * Adequate hematological, hepatic and renal function. Exclusion Criteria * History of other active malignancy. * Prior chemotherapy, radiation therapy, immunosuppressive or investigational therapy for metastatic disease in previous 12 months. * Strong opioids, immunosuppressives, megestrol acetate or other estrogenic hormones (e.g., Saw Palmetto, PC-SPES) within 1 month prior to enrollment. * Brain, liver, or lung metastases; uncontrolled heart, liver, lung, or renal diseases or other serious illness. * Prior splenectomy. * History of severe asthma, anaphylaxis, or other serious adverse reactions to vaccines or any of the antigens included in the skin test. * History of moderate to severe lower limb lymphedema, or recent signs of deep venous thrombosis (DVT) or thrombo-embolic disease, or impending stroke. * History of immunodeficiency or autoimmune disease; positive HIV, HbsAg or anti-HCV. * Impending untreated spinal cord compression or urinary outlet obstruction. * Any medication that might affect immune function. (Exceptions: Nonprescription doses of NSAIDS; acetaminophen or aspirin; low doses of antihistamine therapy; normal range doses of vitamins; and H2 blockers).
References
Publications (0)
Data not yet available
No reference posted for this study.