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Autologous OC-L Vaccine and Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT02452775
Recruitment Status : Terminated
First Posted : May 25, 2015
Last Update Posted : April 24, 2020
Sponsor:
Collaborator:
Ovarian Cancer Research Center
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Primary Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer Biological: OC-L Other: Montanide Other: poly-ICLC (Hiltonol), Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 2015
Actual Primary Completion Date : May 30, 2018
Actual Study Completion Date : May 30, 2018


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



Primary Outcome Measures :
  1. Numbers of Adverse Events [ Time Frame: 3.5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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): NCT02452775


Locations
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United States, Pennsylvania
Ovarian Cancer Research Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Ovarian Cancer Research Center
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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02452775    
Other Study ID Numbers: UPCC 40814
First Posted: May 25, 2015    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Fallopian Tube Diseases
Poly ICLC
Interferon Inducers
Immunologic Factors
Physiological Effects of Drugs