OVax®: A Feasibility Study Using a DNP-Modified Autologous Ovarian Tumor Cell Vaccine as Therapy in Ovarian Cancer Patients After Relapse: A Feasibility Study Using a DNP-Modified Autologous Ovarian Tumor Cell Vaccine as Therapy in Ovarian Cancer Patients After Relapse
To study the toxicity, safety and DTH response of DNP-modified autologous ovarian tumor cell
vaccine and the DTH response to unmodified ovarian tumor cells in patients with relapsed
ovarian cancer:
- To determine the tolerability and toxicity of the treatment regimen
- To determine whether O-Vax induces a DTH response to autologous, DNP-modified ovarian
cancer cells
- To determine whether O-Vax induces a DTH response to autologous, unmodified ovarian
cancer cells
Study Population: Patients with recurrent epithelial ovarian cancer whose therapeutic tumor
surgery provides a mass which yields adequate tumor cells for vaccine preparation and
delayed-type hypersensitivity (DTH) testing
Study Design: A Phase I/IIa double-blind, three-dose, multi-center study
Investigational Product: O-Vax: DNP-modified autologous ovarian tumor cell vaccine
Dosage Form: Cell suspension
Route of Administration: Intradermal
Dosage and Treatment Schedule: Prior to enrollment in the study, one dose of 5 x 106
modified and one dose of 5 x 106 unmodified autologous ovarian cancer cells will be
administered, to establish a negative DTH response at baseline. Three dosing regimens will
be used: 5 x 105, 2.5 x 106, or 5 x 106 DNP-modified autologous ovarian tumor cells. An
initial dose of DNP-modified autologous ovarian tumor cells* followed by cyclophosphamide
then weekly doses of DNP-modified autologous ovarian tumor cells mixed with Bacillus of
Calmette and Guérin (BCG) for 6 weeks, and completed with one dose of DNP-modified
autologous ovarian tumor cells mixed with BCG as a 6 month booster if adequate cells
- count determined prior to aliquoting for cryopreservation
Endpoints: Treatment-emergent and related adverse events, serious adverse events, and Grade
3 and 4 laboratory abnormalities
Other Parameters:
- Delayed-type hypersensitivity skin reactions for assessing the induction of immune
responses to DNP-modified and unmodified autologous ovarian tumor cells
- CA-125 levels
- Survival
- Exploratory analysis incorporating in vitro analysis of lymphocytes separated from
patient blood samples
Duration of Treatment: Up to 6 months
Duration of Subject Participation in Study: Three months from the patient's last vaccine
Duration of Follow-up: Survival information will be collected via phone or visit on a
quarterly basis for each patient beginning 30 days after the last scheduled visit
Number of Subjects Required to Meet Protocol Objectives: 42 evaluable subjects
Number of Study Centers: 3-4
Number of Individual Blood Draws: 13 draws over nine months
Volume of Blood Drawn: 11 Draws of 30 mL/draw (total 360 mL) and two draws of 50mL in
heparinized tubes
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Cell-mediated immunity to autologous tumor cells
3 months
No
Henry E Schea
Study Director
AVAX Technologies
United States: Food and Drug Administration
A/100/0501
NCT00660101
April 2008
September 2013
Name | Location |
---|---|
Cancer Treatment Centers of America (CTCA-Midwestern) | Zion, Illinois 60099 |
Cancer Treatment Centers of America (CTCA-Southwestern) | Tulsa, Oklahoma 74133 |
Cancer Treatment Centers of America (ERMC) | Philadelphia, Pennsylvania 19124 |