Phase I/IIa Trial of Folate Binding Protein Vaccine in Ovarian Cancer
|ClinicalTrials.gov 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
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
U.S. FDA Resources
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.
- 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.
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|