Dendritic Cell Vaccine Therapy in Treating Patients with Prostate Cancer Enrolled on NCI 09-C-0139

Status: Enrolling by Invitation

Description

This pilot clinical trial studies dendritic cell vaccine therapy in treating patients with prostate cancer enrolled on National Cancer Institute (NCI) 09-C-0139. Vaccines made from a person's white blood cells mixed with T-cell receptor gamma alternate reading frame protein (TARP) peptides may help the body build an effective immune response to kill tumor cells.

Eligibility Criteria

Inclusion Criteria

  • Males 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)
  • Eastern Cooperative Oncology Group (ECOG) 0-1
  • Life expectancy of >= 1 year
  • Hemoglobin >= 10.0 gm/dL
  • White blood cells (WBC) >= 2,500/mm^3
  • Absolute lymphocyte count (ALC) >= 500/mm^3
  • Absolute neutrophil count (ANC) >= 1,000/mm^3
  • Platelet count >= 100,000/mm^3
  • Prothrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN) unless receiving clinically indicated anticoagulant therapy
  • Serum glutamic oxaloacetic transaminase (SGOT)/serum glutamate pyruvate transaminase (SGPT) =< 2.5 x ULN
  • Total bilirubin =< 1.5 x ULN
  • Creatinine (Cr) =< 1.5 x ULN
  • Estimated glomerular filtration rate (GFR) (eGFR) >= 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 (including intravenous immunoglobulin [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 asthma 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

Locations & Contacts

Maryland

Bethesda
National Institutes of Health Clinical Center
Status: Enrolling by invitation
Contact: Hoyoung Maeng
Phone: 301-250-5161
NCI - Center for Cancer Research
Status: Enrolling by invitation
Contact: Hoyoung Maeng
Phone: 301-250-5161

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To assess the long-term safety of repeated TARP peptide vaccination following the use of a 1st generation bivalent (09-C-0139) and a 2nd generation multi-epitope (ME) TARP peptide vaccine. Specifically, to document if less than 10% of enrolled patients experience a vaccine-related grade 3 adverse event (local injection site reactions or systemic reactions).

SECONDARY OBJECTIVES:

I. To assess and compare the change in slope log prostate-specific antigen (PSA) from pre-study baseline (-12 months to entry on the current study) to the change in slope log PSA at weeks 3-24 and 3-48 post ME TARP vaccination. (for subjects who are still stage D0)

II. To compare the change in slope log PSA at weeks 3-24 and 3-48 following ME TARP vaccination versus the same change in slope log PSA parameters following 1st generation TARP vaccination on protocol 09-C-0139. (for subjects who are still stage D0)

III. To assess reactivity to wild-type (WT)27-35 (TARP 27-35 peptide vaccine) and epitope-enhanced (EE)29-37-9V TARP peptides (TARP 29-37-9V peptide vaccine) as measured by interferon (IFN)-gamma enzyme-linked immunosorbent spot (ELISPOT) at week 24 and week 48 following immunization with the 2nd generation ME TARP vaccine platform in individuals that have previously received TARP vaccination.

IV. To characterize and compare week 24 and 48 TARP WT27-35 and EE29-37-9V TARP peptide IFN-gamma ELISPOT reactivity following ME TARP vaccination with the week 24 and 48 responses induced with the 1st generation bivalent TARP vaccine in the same individuals.

V. To assess additional cellular and humoral immune responses associated with ME TARP peptide autologous dendritic cell (DC) vaccination using anti-TARP antibodies and TARP-specific CSFE (carboxyfluorescein diacetate, succinimidyl ester) proliferation, additional ELISPOT (perforin and granzyme B), intracellular cytokine staining (ICS) and tetramer assays.

OUTLINE:

Patients receive autologous TARP peptide-pulsed dendritic cell vaccine comprising WT TARP 27-35 peptide epitope, EE TARP 27-35 peptide epitope, and five 20-mer TARP peptides intradermally (ID) at weeks 3, 6, 9, 12, 15 and 24.

After completion of study treatment, patients are followed up at weeks 36, 48, 60, 72, 84, and 96.

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
NCI - Center for Cancer Research

Principal Investigator
Hoyoung Maeng

Trial IDs

Primary ID 15-C-0076
Secondary IDs NCI-2015-00172, P131334, 150076
Clinicaltrials.gov ID NCT02362464