Clinical trial NCT01341652: Phase II PAP Plus GM-CSF Versus GM-CSF Alone for Non-metastatic Prostate Cancer
Official title: Randomized Phase II Trial of a DNA Vaccine Encoding Prostatic Acid Phosphatase (pTVG-HP) Versus GM-CSF Adjuvant in Patients With Non-Metastatic Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2011-04-26
Enrollment: 99
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators are trying to find new methods to treat prostate cancer. The approach the investigators are taking is to try to enhance patients' own immune response against the cancer. In this study the investigators will be testing the effectiveness of a vaccine that may be able to help the body fight prostate cancer.


Eligibility criteria: Inclusion Criteria:

* Histologic diagnosis of adenocarcinoma of the prostate
* 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:

* Small cell or other variant prostate cancer histology
* 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

Primary outcomes:
measure: 2-year Metastasis-Free Survival Rate
timeFrame: 2 years
Secondary outcomes:
measure: Prostate Specific Antigen (PSA) Doubling Time (DT)
timeFrame: up to 9 months
measure: Number and Severity of Observed Toxicities
timeFrame: 2 years
measure: Median Time to Radiographic Disease Progression
timeFrame: up to 2 years
measure: PSA Progression Free Survival
timeFrame: up to 2 years
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Helen Diller Family Comprehensive Cancer Center
state: California
city: Baltimore
country: United States
facility: Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center
state: Maryland
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Douglas McNeel, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.