Brief Title
Autologous OC-L Vaccine and Ovarian Cancer
Official Title
A Randomized Pilot Trial to Test the Addition of Montanide and Polyiclc to Autologous Oxidized Tumor Cell Lysate Vaccine in Combination With Gmcsf in Primary Advanced Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Brief Summary
This is a randomized pilot trial to test the addition of 2 investigational agents, Montanide
and poly-ICLC (a TLR3 agonist) to a backbone of autologous oxidized tumor cell lysate vaccine
(OC-L) administered with GMCSF in subjects with primary epithelial ovarian, fallopian tube,
or primary peritoneal cancer.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Numbers of Adverse Events
Condition
Primary Ovarian Cancer
Intervention
OC-L
Study Arms / Comparison Groups
Arm 1
Description: Subjects in ARM 1 will receive the vaccination with OC-L alone
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
3
Start Date
May 2015
Completion Date
May 30, 2018
Primary Completion Date
May 30, 2018
Eligibility Criteria
Inclusion Criteria:
1. Subject has primary ovarian (including low malignant potential), fallopian tube, or
primary peritoneal cancer FIGO stage III or IV defined surgically at the completion of
initial abdominal surgery.
2. Subject has had cytoreductive surgery and has completed first line platinum based
chemotherapy in an adjuvant or neo-adjuvant setting as part of standard of care
treatment.
3. Subject has no evidence of disease based on radiographical imaging
4. Subject has appropriate tissue available from the cytoreductive surgery tumor lysate
preparation.
5. Lysate must meet release criteria.
6. Subject is 18 years of age or older.
7. Subject has an ECOG performance status of ≤ 2.
8. Subject understood and signed the study specific informed consent.
9. Subjects screened between 1 to 12 weeks after last cycle of chemotherapy.
10. Subjects screened any time after completed last cycle of chemotherapy till progression
or first recurrence of the disease.
11. Subject has had at least 4 weeks of postoperative recovery from surgery prior to
enrollment to ensure complete wound healing.
12. Subjects who screen fails can be re-enrolled if the causation of the screen fail has
been corrected.
Exclusion Criteria:
1. Subject for whom tumor lysate does not meet release criteria
2. Subject has a positive serum Yo antibody (Does not need to be repeated if performed in
the past)
3. Subject has a chronic or acute hepatitis C infection. Subject with an old infection
that has cleared may be included.
4. Subject has a chronic or acute hepatitis B infection. Subject with an old infection
that has cleared may be included.
5. Subject has positive test result at the screening visit for one or more of the
following:
1. HTLV-1/2
2. Anti-HIV 1 Antibody (α-HIV-1)
6. Subject requires or is likely to require more than a two-week course of
corticosteroids for intercurrent illness. Subject must complete the course of
corticosteroids 2 weeks before screening to meet eligibility.
7. Subject has renal insufficiency as defined by a serum creatinine > 2.2 mg/dl or BUN >
40 mg/dl. Note: If creatinine is greater than 1.5 x ULN, creatinine clearance must be
greater than 60ml/min.
8. Subject has proteinuria > 3.5 gm over 24 hrs are not eligible for the study
9. Subject with liver failure as defined by a serum total bilirubin > 2.0 and/or serum
transaminases > 3X the upper limits of normal.
10. Subject has hematopoietic failure at baseline as defined by one of the following:
1. Platelets < 100,000/ mm3
2. WBC < 2,500/mm3
3. Absolute Neutrophil Count (ANC) < 1,000/mm3
4. Absolute lymphocyte count < 200/ mm3
5. Hematocrit < 30%
11. Subject has any acute infection that requires specific therapy. Acute therapy must
have been completed within seven days prior to study enrollment.
12. Subject has a serious, non-healing wound, ulcer, or bone fracture.
13. Subject has a clinically significant cardiovascular disease including:
1. Uncontrolled hypertension;
2. Myocardial infarction or unstable angina within 6 months prior to enrollment
3. New York Heart Association (NYHA) Grade II or greater congestive heart failure
14. Subject has a grade II or greater peripheral vascular disease.
15. Subject has a clinically significant peripheral artery disease, e.g., those with
claudication, within 6 months.
16. Subject has any underlying conditions, which would contraindicate therapy with study
treatment
17. Subject has organ allografts.
18. Subject is receiving medication(s) that might affect immune function. Use of H2
antagonists are prohibited as are all antihistamines five days before and five days
after each injection of study vaccine. However, NSAIDS including COX-2 inhibitors,
acetaminophen or aspirin are permitted.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02452775
Organization ID
UPCC 40814
Responsible Party
Sponsor
Study Sponsor
Abramson Cancer Center of the University of Pennsylvania
Collaborators
Ovarian Cancer Research Center
Study Sponsor
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Verification Date
April 2020