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

For information on this trial in Hebrew, click here for the Israel Cancer Association (external link)

Background Information

Epithelial carcinoma of the ovary is the leading cause of death from gynecological malignancies accounting for more than 15,000 deaths per year in the US and is the second leading cause of death due to gynecological malignancies in the world.
Epithelial cancer of the ovary derives from malignant transformation of the epithelium of the ovarian surface, which is contiguous with the peritoneal mesothelium. The median age of patients with ovarian cancer is 60 years, and the average lifetime risk for women is about 1 in 70.
Although ovarian cancer is a disease that initially spreads throughout the abdominal cavity, there are some cases in which a pleural effusion or involvement of the axillary or inguinal lymph nodes takes place. Patients with abdominal disease frequently have asymptomatic involvement of the pelvic and retroperitoneal nodes, usually documented at the time of surgery.
The mortality associated with ovarian cancer is primarily due to dissemination of the disease within the peritoneal cavity due to the absence of early diagnostic symptoms. Unfortunately, for a woman with a peritoneal cavity involvement, the conventional therapies such as surgery and chemotherapy fail to provide long-term cure.

Trial Objectives

The trial is designed primarily to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of the BC-819 plasmid administered intraperitoneally in patients with advanced stage ovarian cancer who have evidence of ascites.

Trial Design

After obtaining informed consent, patients will be screened over period of up to four weeks. If eligible, each patient will receive nine weekly treatments of BC-819 intraperitoneally, using a catheter previously placed by a surgeon via laparotomy or laparoscopy or by interventional radiology under fluoroscopy.

Adverse events (AEs) and concomitant medication use will be assessed at each visit. Blood chemistries, hematology, coagulation indices, and urinalysis will be assessed two days after the first treatment, then on the day of each subsequent treatment. Patients will be admitted to the hospital on the day of first and fourth treatment and will remain in the hospital for approximately 24 hours after the treatment. All other study procedures and treatments will be performed in the outpatient setting. Patients will be monitored for two hours after treatment.

Patients who do not have progressive disease after the last treatment will be offered continued monthly maintenance treatments and follow-ups for an additional six months.

Serum CA-125 will be assessed monthly throughout the study but no clinical decision will be made based on CA-125. 

Inclusion/Exclusion Criteria

To be eligible to participate in this study, patients must meet a number of inclusion/exclusion criteria.

Enrollment information

For more information fill the information request form. Continue to check this website as trial information and locations are being updated periodically.

Current trial locations are: