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Protocol Details

A Pilot Study of Long Term TARP Vaccination Using A Multi-Epitope TARP Peptide Autologous Dendritic Cell Vaccination in Previously Vaccinated Men on NCI 09-C-0139

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

15-C-0076

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male
Min Age: 18 Years
Max Age: N/A

Referral Letter Required

Yes

Population Exclusion(s)

Female;
Children

Keywords

Multi-epitope;
Tarp Peptide;
Dendritic Cell Vaccine;
D0 Prostate Cancer

Recruitment Keyword(s)

None

Condition(s)

Prostatic Neoplasms;
Neoplasms of Prostate;
Prostate Cancer;
Cancer Of Prostate;
Stage D0 Prostate Cancer

Investigational Drug(s)

Multi-Epitope (ME) TARP autologous dendritic cell vaccine

Investigational Device(s)

None

Intervention(s)

Biological/Vaccine: Multi-epitope (ME) T-cell Receptor Alternate Reading Frame Protein (TARP) vaccine

Supporting Site

National Cancer Institute

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.

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Eligibility

INCLUSION CRITERIA:

-Males greater than or equal to 18 years of age with histologically confirmed adenocarcinoma of the prostate.

-Prior enrollment in NCI protocol 09-C-0139 with receipt of at least 5 doses of TARP peptide vaccine (i.e. completion of primary vaccination series).

-Performance Status: ECOG 0-1, life expectancy of greater than or equal to 1 year.

-Hemoglobin greater than or equal to 10.0 gm/dL, WBC greater than or equal to 2,500/mm3, ALC greater than or equal to 500/mm3, ANC greater than or equal to 1,000/mm3, platelet count greater than or equal to 100,000/mm3.

-PT/PTT less than or equal to 1.5X ULN unless receiving clinically indicated anticoagulant therapy.

-SGOT/SGPT less than or equal to 2.5X ULN, total bilirubin less than or equal to 1.5X ULN, Cr less than or equal to 1.5X ULN, 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.

-HIV negative

-No use of investigational agents within 4 weeks of study enrollment or use of immunosuppressive or immunomodulating agents (including 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 patient s 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.


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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)
NIHBC 10 - CLINICAL CENTER BG RM 3B37
10 CENTER DR
BETHESDA MD 20892
(240) 781-3253
hoyoung.maeng@nih.gov

Hoyoung M. Maeng, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CLINICAL CENTER BG RM 3B37
10 CENTER DR
BETHESDA MD 20892
(240) 781-3253
hoyoung.maeng@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:

NCT02362464

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