Phase Ib Trial of Two Folate Binding Protein Peptide Vaccines (E39 and J65) in Breast and Ovarian Cancer Patients

Summary

This is a single-center, randomized, single-blinded, three-arm phase Ib study of the folate binding protein vaccines E39 and J65. The study target population are patients with breast or ovarian cancer diagnosis who have been treated and are without evidence of disease. Disease-free subjects after standard of care multi-modality therapy will be screened and HLA typed. E39 and J65 are cytotoxic T-lymphocyte-eliciting peptide vaccines that are restricted to HLA-A2+ patients (approximately 50% of the U.S. population).

Conditions

• Breast Cancer
• Ovarian Cancer

Interventions

BIOLOGICAL

E39 peptide vaccine

500mcg of lyophilized E39 peptide is suspended in bacteriostatic saline for injection and then frozen. At the time of vaccine administration, one vial of frozen suspended peptide is thawed and mixed with 250mcg GM-CSF in the syringe. This constitutes the E39 peptide vaccine. For patients randomized to the E39 vaccine arm, the primary vaccine series (PVS) consists of E39 vaccine administered intradermally every three to four weeks for six total vaccinations. After completion of the PVS, patients are assessed for significant residual immunity (SRI). Patients with SRI will be randomized to receive one inoculation of either the E39 vaccine or the J65 vaccine. Patients without SRI will be randomized to receive one inoculation of either the E39 vaccine or the J65 vaccine.

BIOLOGICAL

E39 vaccine then J65 vaccine

The E39 vaccine is prepared as noted above. For the J65 vaccine, 500mcg J65 peptide is suspended in bacteriostatic saline for injection and then frozen. At the time of vaccine administration, one vial of frozen suspended E39 peptide is thawed and mixed with 250mcg GM-CSF in the syringe. This constitutes the J65 vaccine. For patients randomized to this arm, the primary vaccine series (PVS) consists of the E39 vaccine administered intradermally every 3-4 weeks for 3 total vaccinations. Patients are then administered the J65 vaccine every 3-4 weeks for a total of 3 vaccinations. After completion of the PVS, patients are assessed for significant residual immunity (SRI). Patients with SRI will be randomized to receive 1 inoculation of either the E39 vaccine or the J65 vaccine. Patients without SRI will be randomized to receive 1 inoculation of either the E39 vaccine or the J65 vaccine.

BIOLOGICAL

J65 vaccine then E39 vaccine

The E39 and J65 vaccines are prepared as noted above. For patients randomized to this arm, the primary vaccine series (PVS) consists of the J65 vaccine administered intradermally every 3-4 weeks for 3 total vaccinations. Patients are then administered the E39 vaccine every 3-4 weeks for a total of 3 vaccinations. After completion of the PVS, patients are assessed for significant residual immunity (SRI). Patients with SRI will be randomized to receive 1 inoculation of either the E39 vaccine or the J65 vaccine. Patients without SRI will be randomized to receive 1 inoculation of either the E39 vaccine or the J65 vaccine.

Sponsors & Collaborators

• M.D. Anderson Cancer Center

  collaborator OTHER

• COL George Peoples, MD, FACS

  lead FED

Principal Investigators

• Elizabeth Mittendorf, MD · Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-09-30

Primary Completion

2016-12-06

Completion

2016-12-06

Countries

• United States

Study Locations