Autologous OC-DC Vaccine in Ovarian Cancer

Exclusion Criteria

• •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:
• •1. HTLV-1/2
• •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 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:
• •1. Platelets less than 100,000/ mm3
• •2. WBC less than 2,500/mm3
• •3. Absolute Neutrophil Count (ANC) less than 1,000/mm3
• •4. Absolute lymphocyte count less than 200/ mm3
• •5. 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.
• •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 (or allergies to reagents used in this study).
• •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.
• •Subject has clinical symptoms or signs of partial or complete gastrointestinal obstruction or who require parenteral hydration and/or nutrition (For cohort 2, 3, 4 and 5).
• •Subjects with a History of bowel obstruction, including sub-occlusive disease, related to the underlying disease and history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess.
• •Subjects with evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction