Adenocarcinoma of the Ovary Clinical Trial
Official title:
OVax®: A Feasibility Study Using a DNP-Modified Autologous Ovarian Tumor Cell Vaccine as Therapy in Ovarian Cancer Patients After Relapse:
To determine if a vaccine made from the patient's own tumor tissue can stimulate an immune response against the patient's tumor cells. To determine the safety of the vaccine.
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: 4-5
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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03608618 -
Intraperitoneal MCY-M11 (Mesothelin-targeting CAR) for Treatment of Advanced Ovarian Cancer and Peritoneal Mesothelioma
|
Phase 1 |