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

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ClinicalTrials.gov Identifier: NCT02362451
Recruitment Status : Recruiting
First Posted : February 13, 2015
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( 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 vaccine s 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: ME TARP vaccine Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 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
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: 1-Lead-in TARP DC vaccine treatment
All patients to receive autologous multi-epitopeTARP DC vaccine before randomization
Biological: ME TARP vaccine
20x10^6 viable cells/dose at weeks 3, 6, 9, 12, 15 and 24

Experimental: 2-Active TARP DC vaccine treatment
Autologous multi-epitope TARP DC vaccine afterrandomization
Biological: ME TARP vaccine
20x10^6 viable cells/dose at weeks 3, 6, 9, 12, 15 and 24

Placebo Comparator: 3-Placebo
Autologous elutriated monocyte vaccine placeboafter 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. Difference in rate of PSA change pre vs post treatment [ Time Frame: One year pre-enrollment; weeks 3 - 24 post vaccine ]
    PSA Doubling Time (PSADT) andslope log (PSA) will be calculated at every study visit using the PSADT Memorial Sloane Kettering nomogram.


Secondary Outcome Measures :
  1. Progression free survival [ 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.



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Ages Eligible for Study:   18 Years to 99 Years   (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.
  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 PSA and no evidence of metastatic disease by physical examination, CT scan or bone scan.
  4. 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 RTOG-ASSTRO 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 ADT allowed; must be greater than or equal to 6 months since last dose of ADT).
  8. Performance Status: ECOG 0-1 and life expectancy greater than or equal to 1 year.
  9. Hemoglobin greater than or equal to 9.0 gm/dL, WBC greater than or equal to 2,500/mm(3), ALC greater than or equal to 500/ mm(3), ANC greater than or equal to 1,000/mm(3) platelet count greater than or equal to 75,000/mm(3), and PT/PTT less than or equal to 1.5 times ULN unless receiving clinically indicated anticoagulant therapy; SGPT/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); 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 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 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.

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


Contacts
Contact: Lee C England, P.A.-C (240) 858-3649 lee.england@nih.gov
Contact: Hoyoung M Maeng, M.D. (240) 781-3253 hoyoung.maeng@nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    888-624-1937      
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Hoyoung M Maeng, M.D. National Cancer Institute (NCI)

Additional Information:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02362451     History of Changes
Other Study ID Numbers: 150075
15-C-0075
First Posted: February 13, 2015    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2, 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Dendritic Cell Vaccine
Multi Epitope Tarp Peptide
Autolougous Dendritic Cell
D0 Prostate Cancer
Vaccine Therapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs