Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Advanced Adenocarcinoma of the Prostate (Prostate Cancer)
A Phase II Randomized Trial of Recombinant Fowlpox and Recombinant Vaccinia Virus Expressing PSA in Patients With Adenocarcinoma of the Prostate
NCT00005039CI-TRIAL-00009086terminatedPhase 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): Administratively complete.
Summary
Brief summary (as posted)
Randomized phase II trial to determine the effectiveness of vaccine therapy in treating patients who have advanced adenocarcinoma of the prostate (prostate cancer). Vaccines made from a person's prostate cancer cells may make the body build an immune response to kill tumor cells
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Prostate | Prostate Adenocarcinoma | ALIAS | 0.90 |
| Recurrent Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| recombinant fowlpox-prostate specific antigen vaccine | Biological | — | UNRESOLVED |
| recombinant vaccinia prostate-specific antigen vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive recombinant fowlpox-PSA vaccine IM at the MTD from the safety cohort every 4 weeks for 3 courses. Patients then receive recombinant vaccinia-PSA vaccine intradermally every 4 weeks for 2 courses.
- interventionNames
- Biological: recombinant fowlpox-prostate specific antigen vaccine
- Biological: recombinant vaccinia prostate-specific antigen vaccine
- Other: laboratory biomarker analysis
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients receive the same vaccines as in arm I but in reverse order.
- interventionNames
- Biological: recombinant fowlpox-prostate specific antigen vaccine
- Biological: recombinant vaccinia prostate-specific antigen vaccine
- Other: laboratory biomarker analysis
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologically proven adenocarcinoma of the prostate with evidence of metastatic disease including any of the following:
* Lymph node positive and prostate-specific antigen (PSA) at least 10 ng/mL
* Bone scan positive and PSA at least 10 ng/mL
* Prior radical prostatectomy with rising PSA and PSA at least 2 ng/mL
* Prior radiotherapy and PSA at least 10 ng/mL
* Prior cryosurgery and PSA at least 10 ng/mL
* PSA criteria does not apply to patients who are assigned to group B of this study and were previously treated on vaccine trial DFCI-96079
* No symptomatic metastatic disease (no bony pain)
* Complete HLA typing required
* Performance status - ECOG 0 or 1
* WBC greater than 2,000/mm\^3
* Platelet count greater than 100,000/mm\^3
* Bilirubin less than 2.0 mg/dL
* SGPT less than 4 times upper limit of normal
* Creatinine less than 4.0 mg/dL
* No altered immune function such as eczema
* No autoimmune diseases such as the following:
* Autoimmune neutropenia, thrombocytopenia, or hemolytic anemia
* Systemic lupus erythematosus, Sjögren's syndrome, or scleroderma
* Myasthenia gravis
* Goodpasture's syndrome
* Addison's disease, Hashimoto's thyroiditis, or active Graves' disease
* HIV negative
* No allergy or untoward reaction to prior vaccinia (smallpox) vaccination
* No hypersensitivity to eggs
* No prior or concurrent extensive eczema or skin disorders (e.g., extensive psoriasis, burns, impetigo, or disseminated zoster)
* No other concurrent serious illness
* No active infection requiring antibiotics until infection has cleared and antibiotics have been stopped for at least 3 days
* Fertile patients must use effective contraception
* No close contact or household contact with the following high-risk individuals for at least 2 weeks after each vaccination:
* Children under age 5
* Pregnant or nursing women
* Individuals with prior or concurrent extensive eczema or other eczematoid skin disorders
* Individuals with other acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds)
* Immunodeficient or immunosuppressed individuals (by disease or therapy) such as those with HIV infection
* See Disease Characteristics
* See Endocrine therapy
* Prior vaccinia (smallpox) immunization required
* No other concurrent biologic therapy (e.g., interferon or interleukin) for cancer
* No prior chemotherapy for metastatic disease
* No concurrent anticancer chemotherapy
* No prior hormonal therapy for metastatic disease
* Prior neoadjuvant hormonal therapy followed by prostatectomy or radiotherapy allowed
* Patients previously treated with recombinant vaccinia-PSA vaccine may have hormonal therapy since discontinuing that treatment (Group B)
* No concurrent hormonal therapy or steroids
* See Disease Characteristics
* See Endocrine therapy
* No concurrent radiotherapy
* See Disease Characteristics
* See Endocrine therapy
* No prior splenectomy
* At least 3 days since prior antibiotics
* No concurrent immunosuppressive treatment (e.g., after organ transplantation)References
Publications (0)
Data not yet available
No reference posted for this study.