Study Stopped
Administratively complete.
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
4 other identifiers
interventional
86
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2000
CompletedFirst Submitted
Initial submission to the registry
April 6, 2000
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedJanuary 24, 2013
January 1, 2013
7.2 years
April 6, 2000
January 23, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
PSA response
PSA response is assessed at 3 successive monthly determinations, starting 28 days after the final vaccine dose.
Up to 3 months after the final vaccine dose
Study Arms (2)
Arm I
EXPERIMENTALPatients 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.
Arm II
EXPERIMENTALPatients receive the same vaccines as in arm I but in reverse order.
Interventions
Given IM
Given intradermally
Eligibility Criteria
You may qualify if:
- 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
- +38 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph Paul Eder
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2000
First Posted
January 27, 2003
Study Start
January 1, 2000
Primary Completion
March 1, 2007
Last Updated
January 24, 2013
Record last verified: 2013-01