A Phase II Study of PROSTVAC-V (Vaccinia)/TRICOM and PROSTVAC-F (Fowlpox)/TRICOM With GM-CSF in Patients With PSA Progression After Local Therapy for Prostate Cancer
4 other identifiers
interventional
50
1 country
7
Brief Summary
Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. Androgens can cause the growth of prostate cancer cells. Drugs, such as bicalutamide and goserelin, may stop the adrenal glands from making androgens in patients whose tumor cells continue to grow. Giving vaccine therapy together with GM-CSF and, when needed, androgen ablation may be a more effective treatment for prostate cancer. This phase II trial is studying how well giving vaccine therapy together with GM-CSF works in treating patients with prostate cancer that progressed after surgery and/or radiation therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2006
Longer than P75 for phase_2
7 active sites
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
First Submitted
Initial submission to the registry
April 18, 2005
CompletedFirst Posted
Study publicly available on registry
April 19, 2005
CompletedStudy Start
First participant enrolled
February 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedResults Posted
Study results publicly available
April 4, 2013
CompletedJune 30, 2015
December 1, 2013
4.7 years
April 18, 2005
October 19, 2012
June 3, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of Patients Free of PSA Progression at 6 Months (Prior to the Start of Androgen Ablation)
For patients who achieved a \> 50% decline in PSA, an increase in PSA value by 50% over the nadir, confirmed by a second PSA two weeks later is considered progressive disease. The PSA rise must be at least 5 ng/mL or back to pretreatment baseline, whichever is greater. Changes in PSA below 5 ng/mL will not be considered assessable for progression. For patients whose PSA has not decreased by 50%, an increase in PSA value \> 50% of baseline (on trial) or nadir PSA, whichever is lower, confirmed by a repeat PSA two weeks later is considered progressive disease. The PSA must have risen by at least 5 ng/mL.
Assessed at 6 months
Secondary Outcomes (3)
Proportion of Patients With PSA Response
Assessed monthly during the first 24 weeks and then every 3 months for a maximum total of 24 months
Difference Between Day 4 PSA Level and Day 15 PSA Level
Assessed at day 4 and day 15 of cycle 1
The Difference Between PSA Slopes Before and After Treatment
Assessed monthly during the first 24 weeks and then every 3 months for a maximum total of 24 months
Study Arms (1)
Treatment (vaccine therapy)
EXPERIMENTALPatients receive vaccinia-PSA-TRICOM vaccine SC on day 1 and sargramostim (GM-CSF) SC on days 1-4 during weeks 1-4. Beginning in week 5, patients receive fowlpox-PSA-TRICOM vaccine SC on day 1 and GM-CSF SC on days 1-4. Treatment with fowlpox-PSA-TRICOM vaccine and GM-CSF repeats every 4 weeks for 3 courses (weeks 5-16). Beginning in week 17, patients receive fowlpox-PSA-TRICOM vaccine and GM-CSF as above every 12 weeks in the absence of clinical or biochemical disease progression or unacceptable toxicity. Patients with biochemical or clinical disease progression receive androgen ablation therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4 weeks in addition to fowlpox-PSA-TRICOM vaccine and GM-CSF. Treatment continues in the absence of further clinical or biochemical disease progression.
Interventions
Given orally
Given SC
Given SC
Given SC
Eligibility Criteria
You may qualify if:
- Patients with histologically proven prostate cancer and tumors limited to the prostate (including seminal vesical involvement, provided all visible disease was surgically removed) that have completed local therapy and have an elevated PSA after surgery or rising PSA after radiation therapy, as defined below; patients with lymph node involvement (D1) are not eligible
- Histologically confirmed diagnosis of prostate cancer
- Previous treatment with definitive surgery or radiation therapy or both
- No evidence of metastatic disease on physical exam, CT (MRI), and bone scan within 4 weeks prior to randomization
- Prior neoadjuvant/adjuvant hormonal or chemotherapy is allowed if it was last used \>= 1 year prior to enrollment (no prior vaccine/immunotherapy for prostate cancer will be allowed)
- No therapy modulating testosterone levels (such as leuteinizing-hormone releasing-hormone agonists/antagonists and antiandrogens) is permitted within 1 year prior to enrollment; agents such as 5-reductase inhibitors, ketoconazole, megestrol acetate, systemic steroids, and herbal products are not permitted at any time during the period that the PSA values are being collected
- Hormone-sensitive prostate cancer as evident by a serum total testosterone level \> 150 ng/dL at the time of enrollment within 4 weeks prior to randomization
- There must be one PSA measurement (referred to as the baseline PSA) obtained within one week prior to registration; the baseline PSA value must be greater than 0.4 ng/mL (after prostatectomy) or greater than 1.5 ng/mL (after radiation therapy)
- All patients must have evidence of biochemical progression as determined by 3 PSA measurements (PSA1, PSA2, PSA3), each higher than the previous value, each obtained at least 4 weeks apart from the others with the most recent one (PSA3) being the baseline PSA; all of these PSA values must be obtained at the same reference lab; the earliest (PSA1) must be done within 6 months prior to registration.
- PSA doubling time (PSADT) must be less than 12 months, calculated using the following formula:
- PSADT in days = (0.693 (t))/(In (PSA3) - In (PSA2)) Where t = the number of days between PSA3 and PSA2 In = the natural log PSADT in months = PSADT in days divided by 30.4375
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 1
- Leukocytes \>= 3000/mm\^³
- Granulocytes \>= 1500/mm\^3
- Platelet count \>= 100,000/mm\^3
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Baptist Cancer Institute
Jacksonville, Florida, 32207, United States
Northwestern University
Chicago, Illinois, 60611, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Eastern Cooperative Oncology Group
Boston, Massachusetts, 02215, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
New York University Langone Medical Center
New York, New York, 10016, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Statistician
- Organization
- ECOG Statistical Office
Study Officials
- PRINCIPAL INVESTIGATOR
Robert DiPaola
Eastern Cooperative Oncology Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2005
First Posted
April 19, 2005
Study Start
February 1, 2006
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
June 30, 2015
Results First Posted
April 4, 2013
Record last verified: 2013-12