Two-Arm Study of a DNA Vaccine Encoding Prostatic Acid Phosphatase (PAP) in Patients With Non-Metastatic Castrate-Resistant Prostate Cancer

NCT00849121 | Completed Phase 2 Results DMC

• 5 other identifiers: CO08802H-2008-0102NCI-2011-00859A534260SMPH\MEDICINE\HEM-ONC
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are trying to find new methods to treat prostate cancer. The approach 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. The vaccine, called pTVG-HP, is a piece of DNA genetic material that contains genetic code for a protein that is made by the prostate gland, called prostatic acid phosphatase (PAP). The vaccine will be given together with a substance called an adjuvant. Adjuvants are typically given with vaccines and can improve the effect of the vaccine. The adjuvant that will be used in this study is called granulocyte-macrophage colony-stimulating factor (GM-CSF). The main purpose of this study is to find out whether the vaccine generates long-lived immune responses, and whether a better schedule of vaccination can be found by doing frequent laboratory testing for immune responses. The investigators also want to see if the vaccine stimulates any immune reaction against cancer cells.

Conditions

Prostate Cancer

Keywords

Vaccine; pTVG-HP; Prostate Cancer; Castrate Resistant

Outcome Measures

Primary Outcomes (2)

• Number of Participants With > = Grade 2 Autoimmune Events or >=Toxicities at Least Possibly Related to pTVG-HP With GM-CSF Study Treatment.

  The number and severity of toxicity incidents occurring between the pre-treatment and the final off-study evaluation will be collected and assigned an attribution. The toxicities observed will be summarized in terms of types and severities by the NCI Common Terminology Criteria version 3 for each study arm. The number of subjects experiencing grade 2 or higher autoimmune events or grade 3 or higher toxicities felt to be at least possibly related to pTVG-HP with GM-CSF study treatment will be compared between the two arms.

  From the time the patient begins treatment until 30 days after the last treatment with pTVG-HP vaccine, up to a maximum of 2 years

• Number of Participants Who Experience at Least a 3-fold Higher PAP-specific T-cell Frequency or Proliferation Index at One Year Compared to Baseline.

  The number of patients with a T-cell immune response will be determined for each study arm. An immune response will be defined as a PAP-specific T-cell frequency or proliferation index at 1 year that is at least 3-fold higher than the baseline T-cell frequency or proliferation index.

  Baseline and 1 year.

Secondary Outcomes (2)

• The Number of Participants Who Experience at Least a Two-fold Increase in the PSA Doubling Time During the Treatment Period.

  Starting at Treatment Day 0 and continuing every 4-6 weeks until end of treatment period, an average of 2 years

• The Number of Participants Who Are Metastasis-free at One Year.

  one year from study entry

Study Arms (2)

1

EXPERIMENTAL

Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then every 12 weeks until disease progression.

Biological: pTVG-HP with rhGM-CSF

2

EXPERIMENTAL

Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then given every 2-week, 4-week, or 3-month intervals as dictated by cellular immune response measurement.

Biological: pTVG-HP with rhGM-CSF

Interventions

pTVG-HP with rhGM-CSF BIOLOGICAL

pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for 6 total doses, followed by pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. every 3 months until radiographic disease progression

Also known as: DNA-based vaccine encoding PAP

1

Eligibility Criteria

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

You may qualify if:

• Diagnosis of Prostate Cancer
• Castrate Resistant Disease with rising PSA despite continuous treatment with orchiectomy or a LHRH agonist
• Rising PSA after treatment and withdrawal of anti-androgen
• Serum Testosterone \<50ng/mL
• Normal organ function per laboratory tests

You may not qualify if:

• No evidence of immunosuppression or on treatment with immunosuppressive agents
• Cannot have discontinued LHRH agonist treatment (if not previously treated by orchiectomy) within 6 months prior to study entry
• Must not be concurrently taking other medications or supplements with known hormonal effects (other than the LHRH agonist noted above).
• Cannot have any evidence for metastatic disease on bone or CT scan
• Unable or unwilling to undergo two leukapheresis procedure

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

• 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

Interventions

regramostim

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Of the 17 participants enrolled, 16 received at least 6 initial immunizations with pTVG-HP vaccine and were deemed evaluable to be assessed for outcome measure 3.

Results Point of Contact

• Title: Dr. Douglas McNeel
• Organization: University of Wisconsin Carbone Cancer Center

dm3@medicine.wisc.edu

608-265-8131

Study Officials

• Douglas McNeel, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2009
• First Posted: February 23, 2009
• Study Start: March 16, 2009
• Primary Completion: February 17, 2014
• Study Completion: February 17, 2014
• Last Updated: November 21, 2019
• Results First Posted: September 11, 2014

Record last verified: 2019-03

Locations

US (1)