Phase II PAP Plus GM-CSF Versus GM-CSF Alone for Non-metastatic Prostate Cancer
NCT ID: NCT01341652
Last Updated: 2021-01-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
99 participants
INTERVENTIONAL
2011-05-23
2020-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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pTVG-HP vaccine with GM-CSF
pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
pTVG-HP
pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
GM-CSF alone
rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
rhGM-CSF
rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
Interventions
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pTVG-HP
pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
rhGM-CSF
rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Completion of local therapy by surgery and/or ablative radiation therapy at least 3 months prior to entry, with removal or ablation of all visible disease, including seminal vesical and/or local lymph node involvement
* Rising prostate specific antigen (PSA) levels without scan evidence of metastatic disease
* Asymptomatic or mildly symptomatic and life expectancy of at least 4 months
Exclusion Criteria
* Evidence of immunosuppression
* Prior treatment with androgen deprivation except if given neoadjuvantly or adjuvantly with radiation therapy or at time of prostatectomy. In this situation, no more than 24 months of androgen deprivation must have been given and treatment must not have been within 12 months prior to screening for this study.
* Serum testosterone at screening \< 50 ng/dL
* Known bone metastases or lymph node involvement as determined by bone scan or computed tomography (CT) scan of the abdomen and pelvis within 4 weeks of study entry
* Prior vaccine therapy for prostate cancer
* Known allergic reactions to granulocyte-macrophage colony-stimulating factor (GM-CSF)
* Severe intercurrent medical conditions or laboratory abnormalities that would impart, in the judgment of the Medical Monitor, excess risk associated with study participation or study agent administration
18 Years
MALE
No
Sponsors
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University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Douglas McNeel, M.D., PhD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
Countries
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References
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McNeel DG, Eickhoff JC, Johnson LE, Roth AR, Perk TG, Fong L, Antonarakis ES, Wargowski E, Jeraj R, Liu G. Phase II Trial of a DNA Vaccine Encoding Prostatic Acid Phosphatase (pTVG-HP [MVI-816]) in Patients With Progressive, Nonmetastatic, Castration-Sensitive Prostate Cancer. J Clin Oncol. 2019 Dec 20;37(36):3507-3517. doi: 10.1200/JCO.19.01701. Epub 2019 Oct 23.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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University of Wisconsin Carbone Cancer Center
Other Identifiers
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2013-1679
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2011-00965
Identifier Type: REGISTRY
Identifier Source: secondary_id
A534260
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH/MEDICINE/MEDICINE*H
Identifier Type: OTHER
Identifier Source: secondary_id
Protocol Version 10/7/2015
Identifier Type: OTHER
Identifier Source: secondary_id
CO08801
Identifier Type: -
Identifier Source: org_study_id
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