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

This is an interventional treatment trial for Ovarian Cancer focused on measuring Vaccine, Ovarian, Peritoneal Read More

Inclusion Criteria:

• Recurrent stage II to IV ovarian carcinoma or primary peritoneal carcinoma.
• Subjects with prior secondary cytoreductive surgery or aspiration of malignant effusion yielding tumor for lysate preparation.
• Subjects must have sufficient lysate for DCVax-L preparation (> 10 mg of pure protein lysate from tumor, ascites or malignant pleural effusion cell preparation).
• largest tumor nodule ≤ 2.5 cm
• Patients who have achieved complete response following surgery and chemotherapy are still eligible for vaccine.
• may be platinum-sensitive or platinum-resistant
• may have received chemotherapy or other therapy after harvest of tumor
• must have recovered from toxicities of prior chemotherapy or other therapy.
• completed all parenteral investigational therapy 14 days and have completed all oral investigational therapy 7 days prior to enrollment
• must have completed all hormonal therapy 7 days prior to enrollment.
• must have recovered from toxicities of radiation therapy (to grade 2 or less).
• at least 4 weeks postoperative recovery
• coagulation studies w/i normal limits
• ECOG > 2
• Life expectancy of > 4 months.
• must understand and sign the study specific informed consent.

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.