Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Non-Metastatic Prostate Cancer
A Phase II Trial to Determine the Safety, Tolerability and Efficacy of an Allogeneic Whole Cell Vaccine Administered With Autologous Myeloid Dendritic Cells to Patients With Non-Metastatic Androgen Independent Prostate Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was terminated due to funding issues.
Summary
Brief summary (as posted)
RATIONALE: Vaccines made from tumor cells or dendritic cells may help the body build an effective immune response to kill tumor cells. It is not yet known which vaccine is more effective in treating patients with prostate cancer. PURPOSE: This phase II trial is studying how well the combination of a proven effective allogenic whole prostate carcinoma cell (APCC) vaccine co-administered with ex vivo generated dendritic cells (DCs)(DC-APCC) extend the time to prostate cancer progression.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic tumor cell vaccine | Biological | — | UNRESOLVED |
| therapeutic autologous dendritic cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DC-APCC
- description
- Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Biological: allogeneic tumor cell vaccine
- Biological: therapeutic autologous dendritic cells
Primary outcomes (1)
- measure
- Number of Participants Who Are Progression Free at One Year
- timeFrame
- One year
- description
- Progression free was defined as being free of radiographically detectable disease/metastases at one year after registration and having a prostate-specific antigen (PSA) level \<200.0 ng/mL.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate
* Biochemically progressive disease defined by two serial PSA measurements obtained ≥ 1 week apart during ongoing optimal androgen-deprivation therapy (e.g., orchiectomy, luteinizing hormone-releasing hormone \[LHRH\] agonist, or another equivalent hormonal agent)
* Concurrent LHRH agonist or high-dose bicalutamide required (unless patient has undergone prior orchiectomy)
* Has undergone prior standard primary therapy for prostate cancer (e.g., radical prostatectomy, radiotherapy, or an equivalent initial treatment directed towards localized prostate cancer)
* PSA 2.0-100.0 ng/mL
* Serum testosterone \< 50 ng/dL (unless undergoing antiandrogen monotherapy)
* No concurrent evidence of radiological or new clinically palpable metastatic cancer
PATIENT CHARACTERISTICS:
* ECOG performance status 0-1
* Life expectancy ≥ 12 weeks
* WBC ≥ 3,500/µL
* Platelet count ≥ 100,000/µL
* Hemoglobin ≥ 10.0 g/dL
* Creatinine ≤ 2.0 mg/dL
* Alkaline phosphatase ≤ 2.5 times upper limit of normal (ULN)
* AST ≤ 2.5 times ULN
* Fertile patients must use effective contraception
* Willing to provide blood samples for research purposes
* Able to complete questionnaire(s) alone or with assistance
* Able to undergo leukapheresis
* No known immunodeficiency
* No other malignancy within the past 5 years except basal cell or squamous cell carcinoma of the skin treated with local resection only
* No concurrent serious illness
* No known history of positive PPD skin test
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Recovered from prior therapy
* More than 1 month since prior and no concurrent corticosteroids or other immunosuppressive agents
* Inhaled corticosteroids allowed
* More than 1 month since prior and no concurrent estrogens and/or ketoconazole
* More than 3 months since prior and no other concurrent investigational medicinal products
* More than 4 weeks since prior and no concurrent secondary hormonal maneuver with or without a peripheral antiandrogen (e.g., bicalutamide), PC-SPES, or any other herbal medicines used to treat prostate cancer
* No prior prostate cancer vaccine
* No other therapy for prostate cancer (e.g., chemotherapy, immunotherapy, radiotherapy, or new hormonal therapy) during and for 4 months after completion of study therapy
* No other concurrent standard therapy that is potentially curative or proven capable of extending life expectancyReferences
Publications (0)
Data not yet available