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Protocol Details

A Randomized, Placebo-Controlled Phase II Study of Multi-Epitope TARP Peptide Autologous Dendritic Cell Vaccination in Men with Stage D0 Prostate Cancer

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

15-C-0075

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male
Min Age: 18 Years
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children;
Female

Special Instructions

Currently Not Provided

Keywords

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

Recruitment Keyword(s)

None

Condition(s)

Prostatic Neoplasms;
Prostate Cancer

Investigational Drug(s)

Multi-Epitope (ME) TARP autologous dendritic cell vaccine

Investigational Device(s)

None

Intervention(s)

Biological/Vaccine: Autologus elutriated monocyte placebo vaccine
Biological/Vaccine: ME TARP vaccine

Supporting Site

National Cancer Institute

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.

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Eligibility

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 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.

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


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Hoyoung M. Maeng, M.D.
National Cancer Institute (NCI)
BG 10 RM 3B37
10 CENTER DR
BETHESDA MD 20814
(240) 781-3253
hoyoung.maeng@nih.gov

Cynthia Boyle, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 82, Room 120
9030 Old Georgetown Rd
Bethesda, Maryland 20814
(240) 760-6006
boylecm@mail.nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT02362451

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