Phase II PAP Plus GM-CSF Versus GM-CSF Alone for Non-metastatic Prostate Cancer
This study is currently recruiting participants.
Verified April 2013 by University of Wisconsin, Madison
Sponsor:
University of Wisconsin, Madison
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01341652
First received: March 24, 2011
Last updated: April 17, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
|
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
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: | April 17, 2013 |
| 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 May 16, 2013