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

Completed · Phase 1/Phase 2

Conditions studied: Ovarian Cancer, Endometrial Cancer, Fallopian Cancer, Peritoneal Cancer

In brief

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.

Key facts

Study ID

NCT01580696

Run by

COL George Peoples, MD, FACS

People needed

51

Starts

2012-04-01

Expected to finish

2016-07-31

Last updated by the study team

2020-05-04

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.)
• Ovarian or endometrial, fallopian and peritoneal cancer
• 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)
• Stage I-IV but no evidence of disease (NED) after completion of primary therapies
• Post-menopausal or rendered surgically infertile
• HLA-A2+ patients will receive the vaccine; HLA-A2- patients will be eligible to participate in the control group
• Good performance status (Karnofsky > 60%, ECOG ≤ 2)
• CBC, CMP, and CA-125 within 2 months of enrollment
• Capable of informed consent

You may not qualify if…

• Patients will be excluded from the study based on the following criteria:
• Receiving immunosuppressive therapy to include chemotherapy, steroids, or methotrexate
• Not post-menopausal or not rendered surgically infertile
• Pregnancy
• In poor health (Karnofsky < 60%, ECOG > 2)
• Tbili > 1.5, creatinine > 2, hemoglobin < 10, platelets < 50,000, WBC < 2,000
• Active interstitial lung disease; asthma requiring more than as needed bronchodilators for management; or other autoimmune lung disease
• Involved in other experimental protocols (except with permission of the other study PI and completion of the other study dosing regimen)
• History of autoimmune disease

Where it is running

• Mid-Atlantic Gynecologic Oncology & Pelvic Surgery Associates — Annandale, Virginia, United States

Full record on ClinicalTrials.gov

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