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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


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Metastasis-free survival

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Douglas McNeel, M.D., PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Food and Drug Administration

Study ID:

CO08801

NCT ID:

NCT01341652

Start Date:

April 2011

Completion Date:

April 2027

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
University of Wisconsin Carbone Cancer CenterMadison, Wisconsin  53792-5669