Phase I/IIa Trial of Folate Binding Protein Vaccine in Ovarian Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
COL George Peoples, MD, FACS, San Antonio Military Medical Center
ClinicalTrials.gov Identifier:
NCT01580696
First received: April 16, 2012
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

Folate binding protein (FBP) is highly over-expressed in breast, ovarian and endometrial cancers and is the source of immunogenic peptides (E39) that can stimulate cytotoxic T lymphocytes (CTL) to recognize and destroy FBP-expressing cancer cells in the laboratory. The purpose of this study is to test whether a peptide-based vaccine consisting of the E39 peptide mixed with the FDA-approved immunoadjuvant granulocyte macrophage colony-stimulating factor (GM-CSF) is safe and effective at inducing an in vivo peptide-specific immune response. Furthermore, the investigators intend to determine the best dose of the vaccine to utilize to produce this immunity most efficiently. The investigators will determine whether immunity to FBP will prevent clinical recurrence. Additionally, the investigators will compare these results with results from a trial utilizing the E75 peptide (from the HER2/neu protein) in ovarian and endometrial cancer patients in preparation for studying a combination vaccine.


Condition Intervention Phase
Ovarian Cancer
Endometrial Cancer
Fallopian Cancer
Peritoneal Cancer
Biological: E39 peptide vaccine
Other: Clinical tracking for disease progression/recurrence
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/IIa Trial of Folate Binding Protein (FBP) Peptide (E39) Vaccine in Ovarian and Endometrial Cancer Patients

Resource links provided by NLM:


Further study details as provided by San Antonio Military Medical Center:

Primary Outcome Measures:
  • Safety and Local/Systemic Toxicity [ Time Frame: Duration of the vaccine series ] [ Designated as safety issue: Yes ]
    Standard local and systemic toxicities will be collected and graded per the National Cancer Institute Common Terminology Criteria for Adverse Events, v4.03 toxicity scale. For the vaccine series (one vaccine/month for six months), patients will be monitored closely for one hour after vaccine inoculation with questioning, serial exams and vital signs every 15 minutes to observe for a hypersensitivity reaction. Patients will also return to the clinic 48-72 hours after each inoculation for questioning regarding systemic toxicity and to examine and measure inoculation site local reactions.


Secondary Outcome Measures:
  • Disease-free survival [ Time Frame: Disease-free survival up to 36 months ] [ Designated as safety issue: No ]
    Disease-free survival (DFS) for all patients regardless of randomization will be determined by the patients' own physicians at the individual study sites during routine follow-up screening. This will occur every three months for the first 24 months after diagnosis and then every six months for an additional 36 months.


Estimated Enrollment: 60
Study Start Date: April 2012
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Non-vaccine clinically matched control group
Patients who meet all inclusion criteria and none of the exclusion criteria will be HLA typed. HLA-A2+ patients will be offered the vaccine. HLA-A2-negative patients and HLA-A2+ patients who decline the vaccine will be followed clinically as matched controls for disease recurrence/progression.
Other: Clinical tracking for disease progression/recurrence
HLA-A2-negative patients or HLA-A2-positive patients who decline the vaccine will be followed clinically as matched controls for disease recurrence/progression. No experimental treatment will be administered to this group.
Experimental: E39 peptide/GM-CSF vaccine
HLA-A2+ patients receive E39 peptide/GM-CSF vaccine intradermally every 3-4 weeks for a total of up to six inoculations.
Biological: E39 peptide vaccine
100mcg, 500mcg and 1,000mcg of lyophilized E39 peptide is suspended in bacteriostatic water for injection in individual cryovials and frozen. At the time of vaccine administration, the suspended peptide is thawed and mixed thoroughly with 250mcg GM-CSF in the syringe. This constitutes the E39 vaccine.
Other Names:
  • E39 peptide (FBP, 191-199, EIWTHSTKV)
  • GM-CSF (sargramostim)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients will be included in the study based on the following criteria. (Enrollment may commence 1 month from completion of standard primary therapies and up to two years after completion of treatment.)

  1. Ovarian or endometrial, fallopian and peritoneal cancer
  2. Completion of primary first-line therapies (i.e., surgery, chemotherapy, immunotherapy and radiation therapy as appropriate per standard of care for patient's specific cancer)
  3. Stage I-IV but no evidence of disease (NED) after completion of primary therapies
  4. Post-menopausal or rendered surgically infertile
  5. HLA-A2+ patients will receive the vaccine; HLA-A2- patients will be eligible to participate in the control group
  6. Good performance status (Karnofsky > 60%, ECOG ≤ 2)
  7. CBC, CMP, and CA-125 within 2 months of enrollment
  8. Capable of informed consent

Exclusion Criteria:

Patients will be excluded from the study based on the following criteria:

  1. Receiving immunosuppressive therapy to include chemotherapy, steroids, or methotrexate
  2. Not post-menopausal or not rendered surgically infertile
  3. Pregnancy
  4. In poor health (Karnofsky < 60%, ECOG > 2)
  5. Tbili > 1.5, creatinine > 2, hemoglobin < 10, platelets < 50,000, WBC < 2,000
  6. Active interstitial lung disease; asthma requiring more than as needed bronchodilators for management; or other autoimmune lung disease
  7. Involved in other experimental protocols (except with permission of the other study PI and completion of the other study dosing regimen)
  8. History of autoimmune disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01580696

Locations
United States, Virginia
Mid-Atlantic Gynecologic Oncology & Pelvic Surgery Associates
Annandale, Virginia, United States, 22003
Sponsors and Collaborators
COL George Peoples, MD, FACS
Investigators
Principal Investigator: John C Elkas, MD, JD Mid-Atlantic Gynecologic Oncology & Pelvic Surgical Associates
Study Director: COL George E. Peoples, MD Brooke Army Medical Center
  More Information

No publications provided

Responsible Party: COL George Peoples, MD, FACS, Chief, Surgical Oncology, Brooke Army Medical Center, Director and Principal Investigator, Cancer Vaccine Development Program, San Antonio Military Medical Center
ClinicalTrials.gov Identifier: NCT01580696     History of Changes
Other Study ID Numbers: 05-20025/20288
Study First Received: April 16, 2012
Last Updated: August 18, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by San Antonio Military Medical Center:
Folate binding protein
E39 vaccine
Stage I-IV ovarian cancer
Stage I-IV endometrial cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on September 30, 2014