Prostatic Acid Phosphatase (PAP) Vaccine in Patients With Prostate Cancer

NCT00582140 | Completed Phase 1 DMC

• 5 other identifiers: 2004-0365CO04806DOD-A-13390A534260SMPH/MEDICINE
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are trying to find new methods to treat prostate cancer. The approach they investigators are taking is to try to enhance patients own immune response against the cancer. In this study the investigators will be testing the safety of a vaccine that may be able to help the body fight prostate cancer.

Conditions

Prostate Cancer

Keywords

Prostate; Cancer; Stage D0; Non-Metastatic; Rising PSA

Outcome Measures

Primary Outcomes (2)

• The primary objective of this phase I study is to determine if the vaccination with serial intradermal vaccinations of a DNA-based vaccine targeting PAP, with GM-CSF is safe (the investigators will be evaluating the degree of toxicity seen)

  During study treatment and for 15 year follow-up

• To determine whether PAP-specific IFNγ-secreting CD8+ T cells can be generated in patients with stage D0 prostate cancer by means of immunization with a plasmid DNA vaccine encoding PAP.

  12 months

Secondary Outcomes (1)

• Efficacy: Immune Response and PSA response

  During treatment and one year follow-up

Study Arms (3)

Cohort Level 1

EXPERIMENTAL

pTVG-HP (dose 1: 100 μg) with rhGM-CSF (200 μg); administered i.d. biweekly for 6 total doses

Biological: pTVG-HP with rhGM-CSF

Cohort Level 2

EXPERIMENTAL

pTVG-HP (dose 2: 500 μg) with rhGM-CSF (200 μg); administered i.d. biweekly for 6 total doses

Biological: pTVG-HP with rhGM-CSF

Cohort Level 3

EXPERIMENTAL

pTVG-HP (dose 3: 1,500 μg) with rhGM-CSF (200 μg); administered i.d. biweekly for 6 total doses

Biological: pTVG-HP with rhGM-CSF

Interventions

pTVG-HP with rhGM-CSF BIOLOGICAL

pTVG-HP (dose 1: 100 μg) with rhGM-CSF (200 μg); administered i.d. biweekly for 6 total doses

Cohort Level 1

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have histologic diagnosis of adenocarcinoma of the prostate
• Must have completed local therapy by surgery and/or ablative radiation therapy at least 2 months prior to entry.
• Must have clinical stage D0 disease defined by the following: In patients treated by surgery, serum PSA values must be \> 2 ng/ml by two measurements at least two weeks apart. In patients treated with ablative radiation therapy, three consecutive increases in serum PSA must be documented, with at least a one month interval between values with the finalPSA \> 2ng/ml.
• Prior history of a second malignancy is allowed if treated with curative intent disease free for \> 5 years.
• Karnofsky performance score of \> 70

You may not qualify if:

• No evidence of immunosuppression or have been treated with immunosuppressive therapy, such as chemotherapy, chronic treatment dose corticosteroids (greater than the equivalent of 10 mg prednisone per day), or radiation therapy to \>30% of the bone marrow, within 6 months of the first vaccination.
• Must not be on concurrent androgen ablative (hormonal) therapy, or must have completed this therapy at least one month prior to study entry.
• Must not have demonstrated PSA progression during any prior hormonal therapy or chemotherapy.
• Must not have known evidence of bone metastases or non-regional lymph node involvement (stage D2 disease) as determined by bone scan or CT scan. -Must not have been treated previously with another investigational anti- tumor vaccine.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Related Publications (2)

• Johnson LE, Olson BM, McNeel DG. Pretreatment antigen-specific immunity and regulation - association with subsequent immune response to anti-tumor DNA vaccination. J Immunother Cancer. 2017 Jul 18;5(1):56. doi: 10.1186/s40425-017-0260-3.

  PMID: 28716080 RESULT

• Tonelli TP, Eickhoff JC, Johnson LE, Liu G, McNeel DG. Long-term follow up of patients treated with a DNA vaccine (pTVG-hp) for PSA-recurrent prostate cancer. Hum Vaccin Immunother. 2024 Dec 31;20(1):2395680. doi: 10.1080/21645515.2024.2395680. Epub 2024 Aug 29.

  PMID: 39208856 DERIVED

Related Links

• University of Wisconsin Carbone Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Interventions

regramostim

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Douglas McNeel, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 28, 2007
• Study Start: March 1, 2005
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: November 19, 2019

Record last verified: 2015-07

Locations

US (1)