Provenge With or Without pTVG-HP DNA Booster Vaccine in Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Wisconsin, Madison
Sponsor:
Collaborator:
Dendreon
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01706458
First received: October 9, 2012
Last updated: August 25, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to try to enhance subjects' own immune response against prostate cancer. In this study the investigators will be testing the effectiveness of adding pTVG-HP vaccine with Sipuleucel-T (Provenge).


Condition Intervention Phase
Prostate Cancer
Biological: sipuleucel-T
Biological: DNA Vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Trial of Sipuleucel-T, With or Without pTVG-HP DNA Booster Vaccine, in Patients With Castrate-Resistant, Metastatic Prostate Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Measure immune responses following treatment with sipuleucel-T [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free Survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Time to radiographic disease progression [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Measure prostate-specific antigen (PSA) doubling time [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Overall Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Number of Circulating Tumor Cells [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • PAP-specific antibody and T-cell immune responses following treatment with sipuleucel-T and DNA vaccine will be summarized in tabular format. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Logistic regression analysis will be conducted to evaluate whether PAP-specific immune response is associated with prolonged (1-year) progression-free survival. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Logistic regression analysis will be conducted to evaluate whether baseline immune responses predict for immune responses elicited/augmented following treatment with sipuleucel-T +/- DNA vaccine. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • The detection of antigen spread to other prostate associated antigens, and the identification of specific antigens recognized, will be analyzed descriptively. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: February 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: sipuleucel-T
Sipuleucel-T will be administered intravenously per standard of care biweekly, weeks 0, 2, and 4.
Biological: sipuleucel-T
Other Name: Provenge
Experimental: sipuleucel-T with DNA Vaccine

Sipuleucel-T will be administered intravenously per standard of care biweekly, weeks 0, 2, and 4.

Then, DNA vaccine (pTVG-HP (100 µg) with rhGM-CSF (208 µg)) will be administered intradermally biweekly (weeks 6, 8, 10, 12), then every 3 months (months 6 and 9) to complete a 1-year treatment period.

Biological: DNA Vaccine
Other Name: pTVG-HP with rhGM-CSF

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Prostate Cancer
  • Castrate Resistant Disease
  • Progressive disease despite androgen deprivation therapy as defined by rising PSA levels or progressive soft tissue or bony disease
  • Normal organ function per laboratory tests
  • Life expectancy of at least 6 months

Exclusion Criteria:

  • History of life-threatening autoimmune disease
  • Small cell or other variant prostate cancer histology
  • Serum testosterone at screening < 50 ng/dL
  • Prior cytotoxic chemotherapy within 6 months of registration
  • Patients who have undergone splenectomy
  • Radiation therapy within 4 weeks of registration is prohibited, or anticipated need for radiation therapy (e.g. imminent pathological fracture or spinal cord compression) within 3 months of registration.
  • Another malignancy other than non-melanoma skin cancer or carcinoma in situ of the bladder. Subjects with a history of other curatively treated cancers are eligible.
  • Known brain metastases
  • Any antibiotic therapy or evidence of infection within 1 week of registration
  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: NCT01706458

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

Locations
United States, Wisconsin
University of Wisconsin Carbone Cancer Center Recruiting
Madison, Wisconsin, United States, 53792
Principal Investigator: Douglas McNeel, M.D., PhD.         
Sponsors and Collaborators
University of Wisconsin, Madison
Dendreon
Investigators
Principal Investigator: Douglas McNeel, M.D., PhD University of Wisconsin, Madison
Study Chair: Glenn Liu, MD University of Wisconsin, Madison
  More Information

Additional Information:
No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01706458     History of Changes
Other Study ID Numbers: CO11816
Study First Received: October 9, 2012
Last Updated: August 25, 2014
Health Authority: United States: Food and Drug Administration
United States: Data and Safety Monitoring Board

Keywords provided by University of Wisconsin, Madison:
Vaccine
pTVG-HP
Prostate Cancer
Castrate Resistant

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 October 02, 2014