Ovarian Cancer
Conditions
Keywords
ovary, ovarian, immunotherapy, cancer
Brief summary
This Phase II will evaluate a new type of ovarian cancer immunotherapy based on a fundamentally new approach that has been successfully tested in a published clinical study of liver cancer. We will test new tableted preparation, V3-OVA, obtained from hydrolyzed, inactivated blood and tumors of patients with cancer of ovaries. Study will last 3 months, 20 patients will be recruited, given one pill per day for three months. The primary clinical endpoint is effect on tumor size and burden after 3 months. Secondary endpoint will be effect on levels of tumor markers on monthly basis compared to baseline.
Detailed description
Ovarian cancer (OC) - a malignant disease affecting the ovarian tissue - is the sixth most diagnosed cancer among women and causes more deaths than any other cancer of the female reproductive system. For treatment of OC, surgical intervention, chemotherapy, as well as radiation methods are used. Despite treatment, about 70% of patients have a relapse. Many different types of immunotherapy (especially checkpoint inhibitors) of OC being tested, but so far the successes have been insignificant, and serious side effects are frequent and unpredictable. This Phase II will evaluate a new type of ovarian cancer immunotherapy based on a fundamentally new approach that has been successfully tested in a published clinical study of liver cancer. We will test new tableted preparation, V3-OVA, obtained from hydrolyzed, inactivated blood and tumor tissues of patients with cancer of ovaries. Study will last 3 months, 20 patients will be recruited, given one pill per day for three months. The primary clinical endpoint is effect on tumor size and burden after 3 months. Secondary endpoint will be effect on levels of tumor markers on monthly basis compared to baseline.
Interventions
BIOLOGICALTableted vaccine (V3-OVA) containing ovarian cancer antigens
One pill of V3-OVA per day for three months
Sponsors
Immunitor LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
no masking
Intervention model description
Single arm, open label Phase II study in volunteers with ovarian cancer receiving daily dose of one pill of vaccine V3-OVA
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Confirmed diagnosis of ovarian cancer Positive for CA125 tumor marker at above normal threshold level -
Exclusion criteria
Metastases to other sites \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in tumor size and burden compared to baseline | Monthly for 3 months | Intravaginal ultrasonography to measure changes in tumor size and burden |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect on level of serum tumor markers compared to baseline | Monthly for three months | Commonly measured tumor markers associated with ovarian cancer, primarily CA125, at baseline and at study termination |
Countries
Mongolia
Contacts
Primary ContactGalyna Kutsyna, MD, MD/PhD
Backup ContactMarina Tarakanovskaya, MD
Outcome results
None listed