Autologous OC-L Vaccine and Ovarian Cancer

Stopped early · Phase 1

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

In brief

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.

Key facts

Study ID

NCT02452775

Run by

Abramson Cancer Center at Penn Medicine

People needed

3

Starts

2015-05-01

Expected to finish

2018-05-30

Last updated by the study team

2020-04-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Ovarian Cancer Research Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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