Phase I/IIa Trial of Folate Binding Protein Vaccine in Ovarian Cancer
NCT ID: NCT01580696
Last Updated: 2020-05-04
Study Results
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Basic Information
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COMPLETED
PHASE1/PHASE2
51 participants
INTERVENTIONAL
2012-04-30
2016-07-31
Brief Summary
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Detailed Description
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The primary endpoints are the safety and optimal dosing of the vaccine to induce an in vivo peptide-specific immune response. The clinical endpoint is time to recurrence from date of enrollment.
The study will be a multicenter, phase I/IIa trial of the FBP peptide E39 + GM-CSF. The target study population is female civilian and military health care beneficiaries over the age of 18 years with a diagnosis of ovarian, endometrial, fallopian, or peritoneal cancer who have undergone primary surgical and medical therapies, are post-menopausal or have surgically induced menopause, and are currently without evidence of disease. Disease-free subjects after standard of care multi-modality therapy will be screened and HLA typed since the E39 vaccine is specific for HLA-A2+ patients (approximately 40% of the US population). HLA-A2-patients will be followed as prospective clinically matched controls for recurrence.
HLA-A2+ patients who meet all other eligibility criteria will be tested for biomarkers that indicate progression/recurrence of ovarian and advanced uterine cancer FBP. FBP+ and HLA-A2+ patients will be vaccinated with the FBP peptide (E39) and GM-CSF. HLA-A2-negative patients and those individuals who are eligible to receive the vaccine but who decline will be followed clinically as matched controls for disease recurrence/progression.
Treatment will begin within one month of the subject enrollment in the study and confirmation of eligibility. The 1 ml by volume vaccine will be administered intradermally in 0.5 mL inoculums at two different sites within 5 cm of each other. A total of six vaccinations will be given every 3-4 weeks and will be administered in the same lymph node draining area. The dose escalation scheme is for three patients to receive each of the doses: 100, 500, and 1,000 mcg of peptide. Patients will be enrolled consecutively. An additional three patients may receive a given a dose depending on the presence of dose limiting toxicity (DLT). Prior to the fourth vaccination, each patient will be assessed for liver, renal, and hematopoietic function. If organ function is stable and no DLT is seen, then the patient will continue with the series. After the last patient in a given dose group has completed the third inoculation and organ function is proven stable, then the next dose group will be initiated. Optimal biologic dose (OBD) is defined as the minimum dose of the vaccine that gives the most optimal and lasting in vivo immunologic response to the vaccinated peptide. Up to 15 patients will be vaccinated at the OBD.
Additionally, the E39-vaccinated patients will be randomized to receive either E39 or J65 (an attenuated version of E39) as a booster to promote long-term E39-specific immunity. The clinical endpoints are long-term FBP immunity, time to recurrence from date of enrollment and 5-year survival rate. Those individuals who are eligible to receive the vaccine, but who decline and all HLA-A2- patients will be followed clinically as matched controls for disease recurrence/progression
Subjects will be followed for safety issues, immunologic response and clinical recurrence. Subjects will be monitored 48-72 hours after each inoculation for reaction to the inoculation as well as documentation of any adverse effects experienced. Immunologic response will be documented with both ex vivo phenotypic and functional assays as well as in vivo delayed type hypersensitivity (DTH) reactions. All patients will be followed for a total of 5 years to document disease-free status.
The investigators intend to enroll up to 60 patients will be enrolled study-wide (15-24 in the vaccine arm, up to 36 in the control arm). With accrual beginning in April 2012 enrollment of the last patient is anticipated to occur in December 2014 followed by a five-year follow-up period. The duration of the trial is expected to be seven years.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Interventions
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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.
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.
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.
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.
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.
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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
FEMALE
No
Sponsors
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COL George Peoples, MD, FACS
FED
Responsible Party
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COL George Peoples, MD, FACS
Chief, Surgical Oncology, Brooke Army Medical Center, Director and Principal Investigator, Cancer Vaccine Development Program
Principal Investigators
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John C Elkas, MD, JD
Role: PRINCIPAL_INVESTIGATOR
Mid-Atlantic Gynecologic Oncology & Pelvic Surgical Associates
COL George E. Peoples, MD
Role: STUDY_DIRECTOR
Brooke Army Medical Center
Locations
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Mid-Atlantic Gynecologic Oncology & Pelvic Surgery Associates
Annandale, Virginia, United States
Countries
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Other Identifiers
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05-20025/20288
Identifier Type: -
Identifier Source: org_study_id
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