Phase I/IIa Trial of Folate Binding Protein Vaccine in Ovarian Cancer
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ClinicalTrials.gov Identifier: NCT01580696 |
Recruitment Status :
Completed
First Posted : April 19, 2012
Last Update Posted : May 4, 2020
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Condition or disease | Intervention/treatment | Phase |
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Ovarian Cancer Endometrial Cancer Fallopian Cancer Peritoneal Cancer | Biological: E39 peptide (100mcg)/GM-CSF vaccine plus E39 booster Other: Non-vaccine clinically matched control group Biological: E39 peptide (500mcg)/GM-CSF vaccine plus E39 booster Biological: E39 peptide (1000mcg)/GM-CSF vaccine plus E39 booster Biological: E39 peptide (100mcg)/GM-CSF vaccine plus J65 booster Biological: E39 peptide (500mcg)/GM-CSF vaccine plus J65 booster Biological: E39 peptide (1000mcg)/GM-CSF vaccine plus J65 booster | Phase 1 Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 51 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Intervention Model Description: | 3+3 dose escalation study of E39 + GM-CSF in HLA-A2+ patients with HLA-A2- patients followed as a control arm |
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 |
Actual Primary Completion Date : | July 31, 2016 |
Actual Study Completion Date : | July 31, 2016 |

Arm | Intervention/treatment |
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Active Comparator: Non-vaccine clinically matched control group
HLA-A2-negative patients and HLA-A2+ patients who decline the vaccine will be followed clinically as matched controls for disease recurrence/progression.
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Other: Non-vaccine clinically matched control group
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.
Other Name: Clinical tracking for disease progression/recurrence |
Experimental: E39 peptide (100mcg)/GM-CSF vaccine plus E39 booster
HLA-A2+ patients receive 100mg E39 peptide/GM-CSF vaccine intradermally every 3-4 weeks for a total of up to six inoculations followed by 500mg booster inoculations of E39 6 and 12 months after completion of the primary vaccine series.
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Biological: E39 peptide (100mcg)/GM-CSF vaccine plus E39 booster
100mcg 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 at this dose. Subsequently, patients will receive a booster of E39 dosed at 500mcg and mixed with 250mcg of GM-CSF. The boosters will be given at 6 and 12 months after completing the primary vaccine series above. Other Names:
|
Experimental: E39 peptide (500mcg) /GM-CSF vaccine plus E39 booster
HLA-A2+ patients receive 500mg E39 peptide/GM-CSF vaccine intradermally every 3-4 weeks for a total of up to six inoculations followed by 500mg booster inoculations of E39 6 and 12 months after completion of the primary vaccine series.
|
Biological: E39 peptide (500mcg)/GM-CSF vaccine plus E39 booster
500mcg 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 at this dose. Subsequently, patients will receive a booster of E39 dosed at 500mcg and mixed with 250mcg of GM-CSF. The boosters will be given at 6 and 12 months after completing the primary vaccine series above. Other Names:
|
Experimental: E39 peptide (1000mcg) /GM-CSF vaccine plus E39 booster
HLA-A2+ patients receive 1000mg E39 peptide/GM-CSF vaccine intradermally every 3-4 weeks for a total of up to six inoculations followed by 500mg booster inoculations of E39 6 and 12 months after completion of the primary vaccine series.
|
Biological: E39 peptide (1000mcg)/GM-CSF vaccine plus E39 booster
1000mcg 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 at this dose. Subsequently, patients will receive a booster of E39 dosed at 500mcg and mixed with 250mcg of GM-CSF. The boosters will be given at 6 and 12 months after completing the primary vaccine series above. Other Names:
|
Experimental: E39 peptide (100mcg)/GM-CSF vaccine plus J65 booster
HLA-A2+ patients receive 100mg E39 peptide/GM-CSF vaccine intradermally every 3-4 weeks for a total of up to six inoculations followed by 500mg booster inoculations of E39' (J65) 6 and 12 months after completion of the primary vaccine series.
|
Biological: E39 peptide (100mcg)/GM-CSF vaccine plus J65 booster
100mcg 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 at this dose. Subsequently, patients will receive a booster of J65 dosed at 500mcg and mixed with 250mcg of GM-CSF. The boosters will be given at 6 and 12 months after completing the primary vaccine series above. Other Names:
|
Experimental: E39 peptide (500mcg) /GM-CSF vaccine plus J65 booster
HLA-A2+ patients receive 500mg E39 peptide/GM-CSF vaccine intradermally every 3-4 weeks for a total of up to six inoculations followed by 500mg booster inoculations of E39' (J65) 6 and 12 months after completion of the primary vaccine series.
|
Biological: E39 peptide (500mcg)/GM-CSF vaccine plus J65 booster
500mcg 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 at this dose. Subsequently, patients will receive a booster of J65 dosed at 500mcg and mixed with 250mcg of GM-CSF. The boosters will be given at 6 and 12 months after completing the primary vaccine series above. Other Names:
|
Experimental: E39 peptide (1000mcg) /GM-CSF vaccine plus J65 booster
HLA-A2+ patients receive 1000mg E39 peptide/GM-CSF vaccine intradermally every 3-4 weeks for a total of up to six inoculations followed by 500mg booster inoculations of E39' (J65) 6 and 12 months after completion of the primary vaccine series.
|
Biological: E39 peptide (1000mcg)/GM-CSF vaccine plus J65 booster
1000mcg 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 at this dose. Subsequently, patients will receive a booster of J65 dosed at 500mcg and mixed with 250mcg of GM-CSF. The boosters will be given at 6 and 12 months after completing the primary vaccine series above. Other Names:
|
- 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.
- 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, Older Adult) |
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.)
- 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
Exclusion Criteria:
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

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 ClinicalTrials.gov identifier (NCT number): NCT01580696
United States, Virginia | |
Mid-Atlantic Gynecologic Oncology & Pelvic Surgery Associates | |
Annandale, Virginia, United States, 22003 |
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 |
ClinicalTrials.gov Identifier: | NCT01580696 |
Other Study ID Numbers: |
05-20025/20288 |
First Posted: | April 19, 2012 Key Record Dates |
Last Update Posted: | May 4, 2020 |
Last Verified: | April 2020 |
Folate binding protein E39 vaccine Stage I-IV ovarian cancer Stage I-IV endometrial cancer |
Ovarian Neoplasms Carcinoma, Ovarian Epithelial Endometrial Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |
Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Uterine Neoplasms Uterine Diseases Molgramostim Vaccines Sargramostim Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents |