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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02362451
Recruitment Status : Terminated (Slow accrual.)
First Posted : February 13, 2015
Results First Posted : March 8, 2022
Last Update Posted : March 18, 2022
Sponsor:
Information provided by (Responsible Party):
Hoyoung M. Maeng, M.D., National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Prostate Cancer Biological: Autologus elutriated monocyte placebo vaccine Biological: Multi-epitope (ME) T-cell receptor g alternate reading frame protein (TARP) vaccine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled Phase II Study of Multi-Epitope TARP Peptide Autologous Dendritic Cell Vaccination in Men With Stage D0 Prostate Cancer
Actual Study Start Date : July 10, 2015
Actual Primary Completion Date : February 13, 2020
Actual Study Completion Date : February 13, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1/Lead-in T-cell Receptor g Alternate Reading Frame Protein Dendritic Cell (DC) Vaccine Treatment
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
20x10^6 viable cells/dose at weeks 3, 6, 9, 12, 15 and 24

Experimental: 2/Active T-cell Receptor g Alternate Reading Frame Protein Dendritic Cell (DC) Vaccine Treatment
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
20x10^6 viable cells/dose at weeks 3, 6, 9, 12, 15 and 24

Placebo Comparator: 3/Placebo
Autologous elutriated monocyte vaccine placebo after randomization
Biological: Autologus elutriated monocyte placebo vaccine
20x10^6 viable cells/dose at weeks 3, 6, 9, 12, 15 and 24




Primary Outcome Measures :
  1. Change in the Slope Log of Prostate-specific Antigen Pre vs Post Treatment [ Time Frame: One year pre-enrollment; weeks 3-24, and 3 - 48 post vaccine ]
    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.


Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: Week 96 after initial vaccination ]
    PFS is defined as the duration of time from start of vaccine treatment to time of progression or death. Given the study population in biochemically recurrent prostate cancer, progression is defined as 1)"radiographic progression" by computed tomography (CT) or bone scan, 2) prostate-specific antigen doubling time (PSADT) that is 3 month or shorter, 3) PSADT decrease 50% or more compared to enrollment PSADT.


Other Outcome Measures:
  1. Number of Participants With Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) [ Time Frame: 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. ]
    Here is the number of participants with non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

-INCLUSION CRITERIA:

  1. 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.
  2. Must have completed and recovered from all prior definitive therapy (surgery, brachytherapy, cryotherapy or radiotherapy) for the primary tumor, or other definitiveintent local therapy.
  3. 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.
  4. 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.
  5. 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).
  6. For patients following radical prostatectomy: 2 absolute PSA values > 0.2ng/ml.
  7. 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).
  8. Performance Status: Eastern Cooperative Oncology Group (ECOG) 0-1.
  9. 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.
  10. Hepatitis B and C negative (unless the result is consistent with prior vaccination or prior infection with full recovery); human immunodeficiency virus (HIV) negative.
  11. No use of investigational agents within 4 weeks of study enrollment or use of immunosuppressive or immunomodulating agents within 8 weeks of study entry.
  12. No other concurrent anticancer therapy or prior prostate cancer vaccines expressing T-cell receptor alternate reading frame protein (TARP).
  13. 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.

EXCLUSION CRITERIA:

  1. Patients with an active second malignancy other than adequately treated squamous or basal cell carcinoma of the skin.
  2. Patients with active infection.
  3. Patients on immunosuppressive therapy including:

    - Systemic corticosteroid therapy for any reason. Patients receiving inhaled or topical corticosteroids may participate.

  4. Other significant or uncontrolled medical illness. Patients with a remote history of asthma or active mild asthma may participate.
  5. Patients who, in the opinion of the Principal Investigator, have significant medical or psychosocial problems that warrant exclusion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02362451


Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Hoyoung M Maeng, M.D. National Cancer Institute (NCI)
  Study Documents (Full-Text)

Documents provided by Hoyoung M. Maeng, M.D., National Cancer Institute (NCI):
Additional Information:
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Responsible Party: Hoyoung M. Maeng, M.D., Principal Investigator, National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02362451    
Other Study ID Numbers: 150075
15-C-0075
First Posted: February 13, 2015    Key Record Dates
Results First Posted: March 8, 2022
Last Update Posted: March 18, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD recorded in the medical record will be shared with intramural investigators upon request. All collected individual participant data (IPD) will be shared with collaborators under the terms of collaborative agreements.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hoyoung M. Maeng, M.D., National Cancer Institute (NCI):
Dendritic Cell Vaccine
Multi Epitope Tarp Peptide
Autolougous Dendritic Cell
D0 Prostate Cancer
Vaccine Therapy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs