A Phase I Clinical Trial of Autologous Dendritic Cell Vaccine for Recurrent Ovarian or Primary Peritoneal Cancer

Exclusion Criteria

• •not enough lysate for vaccine preparation
• •known brain metastases
• •any of the following positive tests at the screening visit: (HTLV-1/2 ; Hepatitis B, HIV, Hepatitis C, Anti-Yo(cdr2) antibody present in serum
• •on corticosteroids
• •prior IV Cytoxan at maximally tolerated dose
• •serum creatinine \> 2.2 mg/dl or BUN \> 40 mg/dl
• •proteinuria \> 3.5gm over 24 hrs
• •serum total bilirubin \> 2.0 and/or serum transaminases \> 3X the upper limits of normal
• •Platelets \< 100,000/ mm3 ; WBC \< 3,000/mm3 ; Absolute Neutrophil Count (ANC) \< 1,500/mm3 ; Absolute lymphocyte count \< 1000/ mm3 ; Hematocrit \< 30%
• •acute infection that requires specific therapy
• •serious, non-healing wound, ulcer, or bone fracture
• •active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels.
• •history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within 6 months of the first date of treatment on this study.
• •clinically significant cardiovascular disease; this includes: (Uncontrolled hypertension ; Myocardial infarction or unstable angina within 6 months prior to registration ; New York Heart Association (NYHA) Grade II or greater congestive heart failure ; Serious cardiac arrhythmia requiring medication ; Grade II or greater peripheral vascular disease.
• •clinically significant peripheral artery disease, e.g., those with claudication, within 6 months.
• •clinical symptoms or signs of partial or complete gastrointestinal obstruction or who require parenteral hydration and/or nutrition.
• •any underlying conditions which would contraindicate therapy with study treatment (or allergies to reagents used in this study). Subjects with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies.
• •organ allografts.
• •known autoimmune/collagen vascular disorder.
• •on any medications that might affect immune function. Additionally, H2 antagonists are excluded as are all antihistamines five days before and five days after each injection of study drug. NSAIDS including COX-2 inhibitors, acetaminophen or aspirin are exceptions.
• •pregnant or lactating.