Long-Term TARP Vaccination Using a Multi-Epitope TARP Peptide Autologous Dendritic Cell Vaccination in Previously Vaccinated Men on NCI 09-C-0139

NCT02362464 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 15007615-C-0076
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- Few studies or literature are available about the long-term safety of repeated peptide vaccinations in people over a period of time. Long-term vaccination may be needed to control tumors. Researchers gave a group of men a series of vaccine injections over 2 years. Now they want to give those same men the new version of the vaccine. They want to see if it produces different types of immune responses and also ensure that repeated vaccinations are safe. Objectives: \- To find out the long-term safety of repeated T-cell receptor alternate reading frame protein (TARP) peptide vaccinations. Eligibility: \- Men who took part in National Cancer Institute (NCI) protocol 09-C-0139. Design:

• Participants will be screened with blood tests, scans, physical exam, medical history, and an evaluation of how well they perform everyday activities.
• Participants will have apheresis. Blood will be removed with a needle from one arm. A machine will separate the white blood cells. The blood, minus the white cells, will be returned through a needle in the other arm.
• Participants will have 14 visits. At each visit, they will have a physical exam and blood tests. They will discuss any side effects.
• Participants will get vaccine injections at weeks 3, 6, 9, 12, 15, and 24. The vaccine will be made from the participants own cells.
• Participants will get a Vaccine Report Card to complete after receiving vaccine.
• The study lasts 96 weeks.

Conditions

Prostatic Neoplasms; Neoplasms of Prostate; Prostate Cancer; Cancer Of Prostate; Stage D0 Prostate Cancer

Keywords

Multi-epitope; Tarp Peptide; Dendritic Cell Vaccine; D0 Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Grade 3 Adverse Events (AEs) Probably Related to the Vaccine Treatment

  The number of Grade 3 adverse events probably related to the vaccine treatment. Adverse events were measured using the Common Terminology Criteria for Adverse Events (CTCAE v.4.0). Grade 3 is severe.

  Up to 30 days after week 24 vaccination

Secondary Outcomes (4)

• Change in Slope Log PSA From Pre-study Baseline (-12 Months to Entry on the Current Study) to the Change in Slope Log PSA at Weeks 3-24 and 3-48 Post Multi-Epitope (ME) T-cell Receptor Alternate Reading Frame Protein (TARP) Vaccination

  Weeks 3-24 minus baseline, and Weeks 3-48 minus baseline

• Change in Slope Log Prostate Specific-antigen (PSA) Versus the Same Change in Slope Log PSA Parameters Following 1st Generation T-cell Receptor Alternate Reading Frame Protein (TARP) Vaccination on Protocol 09-C-0139

  Weeks 3-24 minus baseline, and Weeks 3-48 minus baseline

• Number of Participants With Reactivity to WT27-35 and EE29-37-9V T-cell Receptor Alternate Reading Frame Protein (TARP) Peptides

  Week 24 and Week 48 following immunization with the 2nd generation Multi-Epitope (ME) TARP

• Number of Participants Positive for T-cell Receptor Alternate Reading Frame Protein (TARP) WT27-35 and EE29-37-9V Peptide Reactivity to That of the 1st Generation TARP Vaccine in the Same Individuals on Protocol 09-C-0139 (NCT00972309) and 15-C0076

  Week 24 and 48 following Multi-Epitope (ME) TARP vaccination

Other Outcomes (1)

• Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v.0)

  Date treatment consent signed to date off study, approximately 82 months and 6 days

Study Arms (1)

Long Term T-cell Receptor Alternate Reading Frame Protein (TARP) Peptide Vaccinations

EXPERIMENTAL

Intradermally given vaccine given at weeks 3, 6, 9, 12, 15 and 24.

Biological: Multi-epitope (ME) T-cell Receptor Alternate Reading Frame Protein (TARP) vaccine

Interventions

Multi-epitope (ME) T-cell Receptor Alternate Reading Frame Protein (TARP) vaccine BIOLOGICAL

dose of 20 x 10\^6 viable cells multiepitope TARP dendritic cell vaccine given intradermally at weeks 3, 6, 9, 12, 15 and 24.

Long Term T-cell Receptor Alternate Reading Frame Protein (TARP) Peptide Vaccinations

Eligibility Criteria

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

You may qualify if:

• Males greater than or equal to 18 years of age with histologically confirmed adenocarcinoma of the prostate.
• Prior enrollment in National Cancer Institute (NCI) protocol 09-C-0139 with receipt of at least 5 doses of T cell receptor gamma alternate reading frame protein (TARP) peptide vaccine (i.e. completion of primary vaccination series).
• Performance Status: Eastern Cooperative Oncology Group (ECOG) 0-1, life expectancy of greater than or equal to 1 year.
• Hemoglobin greater than or equal to 10.0 gm/dL, white blood cell (WBC) greater than or equal to 2,500/mm\^3, absolute lymphocyte count (ALC) greater than or equal to 500/mm\^3, absolute neutrophil count (ANC) greater than or equal to 1,000/mm\^3, platelet count greater than or equal to 100,000/mm\^3.
• Prothrombin time (PT)/partial thromboplastin time (PTT) less than or equal to 1.5X upper limit of normal (ULN) unless receiving clinically indicated anticoagulant therapy.
• Serum glutamic-oxaloacetic transaminase (SGOT)/serum glutamic-pyruvic transaminase (SGPT) less than or equal to 2.5X ULN, total bilirubin less than or equal to 1.5X ULN, creatinine (Cr) less than or equal to 1.5X ULN, estimated glomerular filtration rate (eGFR) greater than or equal to 60 ml/min.
• Hepatitis B and C negative, unless the result is consistent with prior vaccination or prior infection with full recovery.
• Human immunodeficiency virus (HIV) negative
• No use of investigational agents within 4 weeks of study enrollment or use of immunosuppressive or immunomodulating agents (including Intravenous immune globulin (IVIG) within 8 weeks of study entry. Note: Use of topical, inhaled and intranasal steroid therapy is permitted.
• Greater than or equal to 6 weeks since the receipt of chemotherapy or radiation therapy.
• Standard of care medical management of current prostate cancer disease status by the patients local oncologist, e.g., androgen deprivation therapy is allowed.
• Able to understand and provide Informed Consent.
• Must be able and willing to adhere to protocol requirements, visits and vaccination timeline.

You may not qualify if:

• Patients with a second malignancy requiring active treatment.
• Patients with an active infection.
• Patients on immunosuppressive therapy including:
• Systemic corticosteroid therapy for any reason. Patients receiving inhaled, intranasal or topical corticosteroids may participate.
• Other significant or uncontrolled medical illness. Patients with a remote history of or active mild asthma may participate.
• Other serious non-malignancy-associated medical conditions that may be expected to limit life expectancy to less than 2 years.
• Any condition- medical, psychiatric or otherwise, that would preclude informed consent, consistent follow-up or compliance with any aspect of the study.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

TARP; Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Results Point of Contact

• Title: Dr. Hoyoung Maeng
• Organization: National Cancer Institute

maengh@mail.nih.gov

240-781-3253

Study Officials

• Hoyoung M Maeng, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 12, 2015
• First Posted: February 13, 2015
• Study Start: May 12, 2015
• Primary Completion: March 25, 2022
• Study Completion: March 25, 2022
• Last Updated: December 10, 2024
• Results First Posted: September 15, 2022

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data available during the study and indefinitely.
• Access Criteria: Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI).

Locations

US (1)