Phase II PAP Plus GM-CSF Versus GM-CSF Alone for Non-metastatic Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Wisconsin, Madison
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01341652
First received: March 24, 2011
Last updated: August 25, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Biological: pTVG-HP
Biological: rhGM-CSF
Phase 2

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

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Metastasis-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prostate specific antigen (PSA) doubling time [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Median time to radiographic disease progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • The number and severity of observed toxicities in each arm will be compared [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 56
Study Start Date: April 2011
Estimated Study Completion Date: April 2027
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Biological: 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
Active Comparator: 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
Biological: 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 Names:
  • GM-CSF
  • granulocyte-macrophage colony-stimulating factor

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01341652

Contacts
Contact: Cancer Connect 1-800-622-8922 cancerconnect@uwcarbone.wisc.edu

Locations
United States, California
UCSF Helen Diller Family Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94115
Contact: Jay Trovato, RN    877-827-3222    jay.trovato@ucsfmedctr.org   
Principal Investigator: Lawrence Fong, MD         
United States, Wisconsin
University of Wisconsin Carbone Cancer Center Recruiting
Madison, Wisconsin, United States, 53792
Contact: Cancer Connect    800-622-8922      
Principal Investigator: Douglas McNeel, M.D., PhD.         
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Douglas McNeel, M.D., PhD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01341652     History of Changes
Other Study ID Numbers: CO08801
Study First Received: March 24, 2011
Last Updated: August 25, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on August 25, 2014