Provenge With or Without pTVG-HP DNA Booster Vaccine in Prostate Cancer
This study is currently recruiting participants.
Verified May 2013 by University of Wisconsin, Madison
Sponsor:
University of Wisconsin, Madison
Collaborator:
Dendreon
Information provided by (Responsible Party):
Douglas McNeel, University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01706458
First received: October 9, 2012
Last updated: May 10, 2013
Last verified: May 2013
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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 2015 |
| Estimated Primary Completion Date: | June 2014 (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
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: | Douglas McNeel, Principle Investigator, University of Wisconsin, Madison |
| ClinicalTrials.gov Identifier: | NCT01706458 History of Changes |
| Other Study ID Numbers: | CO11816 |
| Study First Received: | October 9, 2012 |
| Last Updated: | May 10, 2013 |
| 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 May 23, 2013