This is a prospective, open-label, randomized, parallel group, Phase 1/2 study in female
patients with Stage III/IV epithelial ovarian cancer. The study will compare the
pharmacokinetic profile of OvaRex MAb-B43.13 ascites fluid product and OvaRex MAb-B43.13
cell culture product. The study will also evaluate the safety of the cell culture product
and the immune responses in patients following treatment. The study is being conducted in
three phases:
1. The pharmacokinetic assessment phase will include at least 24 patients, who will be
randomized into two treatment groups to receive a single 2 mg dose of either ascites
fluid product or cell culture product.
2. The treatment phase will continue administration of two more monthly doses (weeks 4 and
8) and all patients will receive cell culture product. Study patients will be followed
for safety and immune response through week 20.
3. The continuation phase will continue administration of cell culture product at the
discretion of the investigator on a quarterly schedule for up to 104 weeks in eligible
patients who tolerate therapy. Patients who continue treatment will be followed for
serious adverse events and all patients will be followed for survival for up to 2 years
after first treatment.
Interventional
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
United States: Food and Drug Administration
OVA-Gy-16
NCT00034138
March 2002
December 2007
Name | Location |
---|---|
MD Anderson Cancer Center | Houston, Texas 77030-4096 |
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
Walt Disney Memorial Cancer Institute | Orlando, Florida 32803 |
Women's Cancer Research Foundation | Miami, Florida 33143 |
St. Joseph's Medical Center | South Bend, Indiana 46634 |
Magee-Women's Hospital | Pittsburgh, Pennsylvania 15213 |
Baptist Hospital of East Tennessee | Knoxville, Tennessee 37920 |
Mary Babb Randolph Cancer Center | Morgantown, West Virginia 26506 |