Clinical trial · Interventional
Long-Term TARP Vaccination Using a Multi-Epitope TARP Peptide Autologous Dendritic Cell Vaccination in Previously Vaccinated Men on NCI 09-C-0139
A Pilot Study of Long Term TARP Vaccination Using A Multi-Epitope TARP Peptide Autologous Dendritic Cell Vaccine in Previously Vaccinated Men on NCI 09-C-0139.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Of Prostate | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Neoplasms of Prostate | Prostate Neoplasm | ALIAS | 0.90 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
| Stage D0 Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multi-epitope (ME) T-cell Receptor Alternate Reading Frame Protein (TARP) vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Long Term T-cell Receptor Alternate Reading Frame Protein (TARP) Peptide Vaccinations
- description
- Intradermally given vaccine given at weeks 3, 6, 9, 12, 15 and 24.
- interventionNames
- Biological: Multi-epitope (ME) T-cell Receptor Alternate Reading Frame Protein (TARP) vaccine
Primary outcomes (1)
- measure
- Number of Grade 3 Adverse Events (AEs) Probably Related to the Vaccine Treatment
- timeFrame
- Up to 30 days after week 24 vaccination
- description
- 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.
Secondary outcomes (4)
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
* INCLUSION CRITERIA: * 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. EXCLUSION CRITERIA: * 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. * Patients who, in the opinion of the Principal Investigator, have significant medical or psychosocial problems that warrant exclusion including: * 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.
References
Publications (0)
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