Ovarian Cancer - Phase I/IIa Clinical Trial of BC-819 - Inclusion/Exclusion Criteria

Inclusion Criteria

Patients must:

• Provide written informed consent and be at least 18 years of age.
• Have failed at least two different primary chemotherapy regimens and have primary or secondary platinum resistant disease.
• Have histopathologically documented epithelial ovarian carcinoma.
• Have evidence of intra-abdominal disease; disease may be measurable or non-measurable.
• Have at least grade 1 (mild) ascites: that is observed by ultrasound.
• Have presence of malignant cells in ascites fluid.
• Be able to tolerate placement of IP catheter.
• Be at least 4 weeks from last treatment to allow recovery from prior toxicity (with the exception of hormonal therapy where a 1-week wash-out period is sufficient, weekly chemotherapy where a two-week washout period is sufficient; and radiation therapy where a 3-week recovery period is sufficient.
• Have a Karnofsky performance status score of ≥ 70%.
• Not be of child-bearing potential.
• Have a life expectancy of ≥ 3 months.
• Have serum creatinine < 2.0 mg/dL, total bilirubin less than the institution's 3x upper limit of normal (ULN); AST and ALT ≤ 2.5 x ULN, PT, PTT, and PT/INR within normal limits, absolute neutrophil count (ANC) > 1,500 x 103 cells/mL, platelets ≥ 100,000/mL, and hemoglobin ≥ 10 mg/dL.
• Have a biopsy specimen or an ascites fluid that is positive for H19 expression.
• Have screening procedures completed within 4 weeks before starting treatment.
• No significant history of cardiac disease, i.e., uncontrolled hypertension, unstable angina or congestive heart failure.
• No prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer.
• No plans to receive concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy or any other type of therapy for treatment of cancer while on this protocol.

Exclusion Criteria

Patients must not:

• Have evidence of extraperitoneal disease.
• Have known brain metastases.
• Have known HIV infection.
• Have known active viral or bacterial infections.
• Have presence of any psychological, familiar, sociological, or geographical condition potentially hampering compliance with the study protocol or follow up schedule.
• Have a medical condition contraindicated for laparotomy, laparoscopy, or surgery.
• Have loculated ascites (i.e. ascites compartmentalized in different "pockets").
• Have a history of coagulopathy.

Return to Clinical Trial Description.