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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01580696
Recruitment Status : Unknown
Verified November 2015 by COL George Peoples, MD, FACS, San Antonio Military Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : April 19, 2012
Last Update Posted : November 17, 2015
Information provided by (Responsible Party):
COL George Peoples, MD, FACS, San Antonio Military Medical Center

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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2012
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. Safety and Local/Systemic Toxicity [ Time Frame: Duration of the vaccine series ]
    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 :
  1. Disease-free survival [ Time Frame: Disease-free survival up to 36 months ]
    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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01580696

United States, Virginia
Mid-Atlantic Gynecologic Oncology & Pelvic Surgery Associates
Annandale, Virginia, United States, 22003
Sponsors and Collaborators
COL George Peoples, MD, FACS
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

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 Identifier: NCT01580696     History of Changes
Other Study ID Numbers: 05-20025/20288
First Posted: April 19, 2012    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015

Keywords provided by COL George Peoples, MD, FACS, 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
Endometrial Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Uterine Diseases
Folic Acid
Vitamin B Complex
Immunologic Factors
Physiological Effects of Drugs
Growth Substances