Autologous OC-DC Vaccine in Ovarian Cancer

Completed · Early Phase 1

Conditions studied: Chemotherapy, Tumor, Ovarian Cancer

In brief

This is a Five cohort sequential clinical trial for subjects with recurrent ovarian, fallopian tube, or primary peritoneal cancer to determine the feasibility and safety as well as immunogenicity of OC-DC, an autologous vaccine comprised of autologous dendritic cells (DC) loaded in vitro with lysate from autologous oxidized tumor cells, administered intranodally alone, or in combination with intravenous Bevacizumab and cyclophosphamide or in combination with intravenous Bevacizumab, cyclophosphamide and aspirin. Study duration is 24 months.

Key facts

Study ID

NCT01132014

Run by

Abramson Cancer Center at Penn Medicine

People needed

67

Starts

2010-05-01

Expected to finish

2018-05-30

Last updated by the study team

2018-06-11

Who can join

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

You may not qualify if…

• Subject for whom tumor lysate does not meet release criteria
• Subject has a positive serum Yo antibody
• Subject whose groins are not accessible.
• 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 greater than 2.2 mg/dl or BUN greater than 40 mg/dl. Note: If creatinine is greater than 1.5 x ULN, creatinine clearance must be greater than 60ml/min.
• Subject has proteinuria greater than 3.5 gm over 24 hrs are not eligible for the study (cohort 2 only)
• Subject with liver failure as defined by a serum total bilirubin greater than 2.0 and/or serum transaminases greater than 3X the upper limits of normal.
• Subject has hematopoietic failure at baseline as defined by one of the following:
• Platelets less than 100,000/ mm3
• WBC less than 2,500/mm3
• Absolute Neutrophil Count (ANC) less than 1,000/mm3
• Absolute lymphocyte count less than 200/ mm3
• Hematocrit less than or equal to 30 percent
• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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