Multi-Epitope TARP Peptide Autologous Dendritic Cell Vaccination in Men With Stage D0 Prostate Cancer

NCT02362451 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: 15007515-C-0075
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- Men who continue to have an elevated or rising prostate specific antigen (PSA) level after their primary prostate cancer treatment are at increased risk for their cancer to progress. The time it takes to progress is highly variable. One way to predict this progression is based on the change in PSA levels over time. This is called the PSA doubling time (PSADT). Researchers want to test a vaccine on men with Stage D0 prostate cancer. Stage D0 means the PSA has become detectable again or has started to rise after primary treatment, but has not spread to other organs. Objectives: \- To test a vaccines effectiveness on the rate of PSA increase using PSADT and tumor growth rates. Eligibility: \- Men with Stage D0 prostate cancer with a PSADT between 3 and 15 months. Design:

• Participants will be screened with blood tests, scans, physical exam, and medical history. Their prostate cancer will be confirmed.
• Participants will undergo 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 injections of either the vaccine or placebo at weeks 3, 6, 9, 12, 15, and 24. Both will be made from the participants own cells.
• Participants will be selected randomly to receive either active vaccine or placebo. For every two participants assigned to active vaccine, one participant will be assigned to placebo vaccine.
• Participants will get a Vaccine Report Card to to complete after receiving vaccine.
• The study lasts 96 weeks.

Conditions

Prostatic Neoplasms; Prostate Cancer

Keywords

Dendritic Cell Vaccine; Multi Epitope Tarp Peptide; Autolougous Dendritic Cell; D0 Prostate Cancer; Vaccine Therapy

Outcome Measures

Primary Outcomes (1)

• Change in the Slope Log of Prostate-specific Antigen Pre vs Post Treatment

  PSA Doubling Time (PSADT) and slope log (PSA) were calculated at every study visit using the PSADT Memorial Sloane Kettering nomogram. The values were calculated to demonstrate the rate of rise of PSA, expressed as the velocity in nanograms/mL/year, or the PSA doubling time, in months or years. PSA is a tumor marker for prostate cancer and after surgery (undetectable - e.g. \<0.2 ng/mL) or radiation PSA should fall to a very low level when the disease is effectively treated. When PSA increases (\>2.0 ng/mL) after surgery or radiation that could mean recurrence of the disease. If prostate cancer is growing slower or shrinking after the treatment, PSADT can be longer while PSA slope log is shorter as tumor will make less PSA.

  One year pre-enrollment; weeks 3-24, and 3 - 48 post vaccine

Secondary Outcomes (1)

• Progression Free Survival (PFS)

  Week 96 after initial vaccination

Other Outcomes (1)

• Number of Participants With Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)

  Date treatment consent signed to date off study, approximately 54 months and 13 days for cohort 1 and 5 months and 9 days for cohort 2.

Study Arms (3)

1/Lead-in T-cell Receptor g Alternate Reading Frame Protein Dendritic Cell (DC) Vaccine Treatment

EXPERIMENTAL

All patients to receive autologous multi-epitope T-cell receptor g alternate reading frame protein (TARP) DC vaccine before randomization

Biological: Multi-epitope (ME) T-cell receptor g alternate reading frame protein (TARP) vaccine

2/Active T-cell Receptor g Alternate Reading Frame Protein Dendritic Cell (DC) Vaccine Treatment

EXPERIMENTAL

Autologous multi-epitope T-cell receptor g alternate reading frame protein (TARP) DC vaccine after randomization

Biological: Multi-epitope (ME) T-cell receptor g alternate reading frame protein (TARP) vaccine

3/Placebo

PLACEBO COMPARATOR

Autologous elutriated monocyte vaccine placebo after randomization

Biological: Autologus elutriated monocyte placebo vaccine

Interventions

Autologus elutriated monocyte placebo vaccine BIOLOGICAL

20x10\^6 viable cells/dose at weeks 3, 6, 9, 12, 15 and 24

3/Placebo

Multi-epitope (ME) T-cell receptor g alternate reading frame protein (TARP) vaccine BIOLOGICAL

20x10\^6 viable cells/dose at weeks 3, 6, 9, 12, 15 and 24

1/Lead-in T-cell Receptor g Alternate Reading Frame Protein Dendritic Cell (DC) Vaccine Treatment; 2/Active T-cell Receptor g Alternate Reading Frame Protein Dendritic Cell (DC) Vaccine Treatment

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. Histology confirmation must be documented with a formal pathology report. Notes from an outside physician describing the pathologic findings (based on a prior review of the full pathology report) may be used if unable to obtain the original pathology report. This will eliminate the need for an additional invasive tissue biopsy.
• Must have completed and recovered from all prior definitive therapy (surgery, brachytherapy, cryotherapy or radiotherapy) for the primary tumor, or other definitiveintent local therapy.
• Stage D0 disease with documented biochemical progression documented by rising prostate specific-antigen (PSA) and no evidence of metastatic disease by physical examination, computed tomography (CT) scan or bone scan.
• Prostate specific-antigen doubling time (PSADT) greater than or equal to 3 months and less than or equal to 15 months:
• Patients must have greater than or equal to 3 PSA measurements over greater than or equal to 3 months.
• The interval between PSA measurements must be greater than or equal to 4 weeks.
• For patients following definitive radiation therapy or cryotherapy: a rise in PSA of \> 2ng/mL above the nadir (per Radiation Therapy Oncology Group (RTOG)-American Society for Therapeutic Radiology and Oncology (ASTRO) consensus criteria).
• For patients following radical prostatectomy: 2 absolute PSA values \> 0.2ng/ml.
• Non-castrate level of testosterone: greater than or equal to 50 ng/dL (prior antiandrogen treatment (ADT) allowed; must be greater than or equal to 6 months since last dose of ADT).
• Performance Status: Eastern Cooperative Oncology Group (ECOG) 0-1.
• Hemoglobin greater than or equal to 9.0 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 75,000/mm(3), and prothrombin time (PT)/Partial thromboplastin time (PTT)PTT less than or equal to 1.5 times upper limit of normal (ULN) unless receiving clinically indicated anticoagulant therapy; serum glutamic-pyruvic transaminase (SGPT)/Serum glutamic oxaloacetic transaminase (SGOT) less than or equal to 3 times ULN, total bilirubin less than or equal to 1.5 times ULN; creatinine less than or equal to 1.5 times ULN and estimated GFR (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 within 8 weeks of study entry.
• No other concurrent anticancer therapy or prior prostate cancer vaccines expressing T-cell receptor alternate reading frame protein (TARP).
• No alternative medications or nutriceuticals known to alter PSA (e.g. phytoestrogens and saw palmetto). Note: patients receiving medications for urinary symptoms such as Flomax or 5-alpha reductase inhibitors (finasteride and dutasteride) on a chronic stable dose for at least 3 months prior to study enrollment are allowed.

You may not qualify if:

• Patients with an active second malignancy other than adequately treated squamous or basal cell carcinoma of the skin.
• Patients with active infection.
• Patients on immunosuppressive therapy including:
• \- Systemic corticosteroid therapy for any reason. Patients receiving inhaled or topical corticosteroids may participate.
• Other significant or uncontrolled medical illness. Patients with a remote history of asthma or active mild asthma may participate.

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

hoyoung.maeng@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: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• 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: July 10, 2015
• Primary Completion: February 13, 2020
• Study Completion: February 13, 2020
• Last Updated: March 18, 2022
• Results First Posted: March 8, 2022

Record last verified: 2022-03

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)