Spots Global Cancer Trial Database for Trial of Autologous, Hapten-Modified Vaccine, OVAX, in Patients With Relapsed Stage III or IV Ovarian Cancer

Study Description

Brief Summary: 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.

Detailed Description: 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

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Contact Details

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