Autologous OC-L Vaccine and Ovarian Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Primary Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer

Intervention / Treatment
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* Biological: OC-L
* Other: Montanide
* Other: poly-ICLC (Hiltonol),


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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. Subject has no evidence of disease based on radiographical imaging Subject has appropriate tissue available from the cytoreductive surgery tumor lysate preparation. Lysate must meet release criteria. Subject is 18 years of age or older. Subject has an ECOG performance status of ≤ 2. Subject understood and signed the study specific informed consent. Subjects screened between 1 to 12 weeks after last cycle of chemotherapy. Subjects screened any time after completed last cycle of chemotherapy till progression or first recurrence of the disease. Subject has had at least 4 weeks of postoperative recovery from surgery prior to enrollment to ensure complete wound healing. Subjects who screen fails can be re-enrolled if the causation of the screen fail has been corrected. Exclusion Criteria: Subject for whom tumor lysate does not meet release criteria Subject has a positive serum Yo antibody (Does not need to be repeated if performed in the past) Subject has a chronic or acute hepatitis C infection. Subject with an old infection that has cleared may be included. Subject has a chronic or acute hepatitis B infection. Subject with an old infection that has cleared may be included. Subject has positive test result at the screening visit for one or more of the following: HTLV-1/2 Anti-HIV 1 Antibody (α-HIV-1) 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. 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. Subject has proteinuria > 3.5 gm over 24 hrs are not eligible for the study Subject with liver failure as defined by a serum total bilirubin > 2.0 and/or serum transaminases > 3X the upper limits of normal. Subject has hematopoietic failure at baseline as defined by one of the following: Platelets < 100,000/ mm3 WBC < 2,500/mm3 Absolute Neutrophil Count (ANC) < 1,000/mm3 Absolute lymphocyte count < 200/ mm3 Hematocrit < 30% Subject has any acute infection that requires specific therapy. Acute therapy must have been completed within seven days prior to study enrollment. Subject has a serious, non-healing wound, ulcer, or bone fracture. Subject has a clinically significant cardiovascular disease including: Uncontrolled hypertension; Myocardial infarction or unstable angina within 6 months prior to enrollment New York Heart Association (NYHA) Grade II or greater congestive heart failure Subject has a grade II or greater peripheral vascular disease. Subject has a clinically significant peripheral artery disease, e.g., those with claudication, within 6 months. Subject has any underlying conditions, which would contraindicate therapy with study treatment Subject has organ allografts. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Subjects in ARM 1 will receive the vaccination with OC-L alone | Biological: OC-L<br> <br> |
| Experimental: Arm 2<br>subjects in ARM 2 will receive vaccination with OC-L admixed with Montanide, | Other: Montanide<br> <br> |
| Experimental: Arm 3<br>subjects in ARM3 will receive vaccination with OC-L admixed with 1 mg poly-ICLC (Hiltonol) | Other: poly-ICLC (Hiltonol),<br> <br> |
| Experimental: Arm 4<br>subjects in ARM 4 will receive vaccination with OC-L admixed with both Montanide and 1 mg poly-ICLC. | Biological: OC-L<br> <br> Other: Montanide<br> <br> Other: poly-ICLC (Hiltonol),<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numbers of Adverse Events |  | 3.5 years |