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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

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Conditions:		Adenocarcinoma of the Ovary
Purpose:		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.
Study Summary:		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
Criteria:		Inclusion Criteria: Screening Phase - Stage III or IV adenocarcinoma of ovary that has relapsed following original platinum-based chemotherapy followed by no more than 4 salvage chemotherapy regimens - Candidate for surgery to excise the tumor - Signed informed consent for tumor acquisition Treatment Phase - At least 18 years of age - Standard surgical debulking to maximum extent possible - Adequate amount of tumor tissue obtained from surgical debulking to prepare a series of vaccines and skin test materials. - Administration of intraperitoneal chemotherapy following surgical debulking Intraperitoneal drug to consist of a taxane (paclitaxel or docetaxel) Dose of taxane: paclitaxel=60-75 mg/m2 / weekly x 4 or docetaxel = 25 mg/m2 - weekly x 4 - Vaccines and DTH materials pass lot release - Minimum of 2 weeks and maximum of 6 weeks following last dose of intraperitoneal chemotherapy - Immunocompetent, as determined by anergy panel performed 1 week after last dose of intraperitoneal chemotherapy (baseline PPD+ patients allowed) - Expected survival of at least 6 months - Karnofsky performance status ³ 80 - Signed informed consent for protocol participation Exclusion Criteria: - Alkaline phosphatase > 2.5 x ULN - Total bilirubin > 2.0 mg/dL - Creatinine > 2.0 mg/dL - Hemoglobin < 10.0 g/dL - WBC < 3,000 /mm3 - Platelet count < 100,000/mm3 - Major field radiotherapy within 6 months prior to participation in the study - Brain metastases, unless successfully treated at least 6 months prior to entry - Prior immunotherapy (interferons, tumor necrosis factor, other cytokines [e.g., interleukins], biological response modifiers, or monoclonal antibodies) within 4 weeks prior to participation in the study - Prior splenectomy - Concurrent use of systemic steroids (Note: Topical steroid therapies [applied to the skin] are not contraindicated for participation in the study, provided these are not applied to either arm. Inhaled aerosol steroids are not contraindicated for participation in the study.) - Concurrent use of immunosuppressive drugs - Concurrent use of antitubercular drugs (isoniazid, rifampin, streptomycin) - Other malignancy within 5 years except curatively treated non-melanomatous skin cancer and curatively treated carcinoma in situ of the uterine cervix - Concurrent autoimmune diseases, e.g., systemic lupus erythematosus, multiple sclerosis or ankylosing spondylitis - Concurrent medical condition that would preclude compliance or immunologic response to study treatment - Concurrent serious infection or other serious medical condition - Receipt of any investigational medication within 4 weeks prior to participation in the study - Known gentamicin sensitivity - Anergic, defined by the inability to make a DTH to at least one of the following: candida, mumps, tetanus, trichophyton (based upon availability), or PPD - Vaccine lot release failure
NCT ID:		NCT00660101
Primary Contact:		Study Director Henry E Schea AVAX Technologies
Backup Contact:		N/A
Location Contact:		Tulsa, Oklahoma 74133 United States JJ Hale, BS,CCRC Phone: 918-286-5449 Email: JJ.hale@ctca-hope.com Site Status: Recruiting

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