Phase 2
Completed N=14
Long-Term TARP Vaccination Using a Multi-Epitope TARP Peptide Autologous Dendritic Cell Vaccination in Previously Vaccinated Men on NCI 09-C-0139
Prostate Cancer · Neoplasms of Prostate · Cancer Of Prostate · Stage D0 Prostate Cancer
Source: ClinicalTrials.gov NCT02362464 ↗
Enrolled (actual)
14
Serious AEs
7.1%
Results posted
Sep 2022
Primary outcomePrimary: Number of Grade 3 Adverse Events (AEs) Probably Related to the Vaccine Treatment — 1 Adverse events
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Grade 3 Adverse Events (AEs) Probably Related to the Vaccine Treatment |
1 | — |
| SECONDARY 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 |
-0.00; -0.01 | — |
| SECONDARY 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 |
-0.06; -0.00; -0.03; -0.01 | — |
| SECONDARY Number of Participants With Reactivity to WT27-35 and EE29-37-9V T-cell Receptor Alternate Reading Frame Protein (TARP) Peptides |
5; 9; 5; 4 | — |
| SECONDARY 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 |
7; 6; 8; 8 | — |
Eligibility Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02362464). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.