NCT00660101UnknownPhase 1
OVax®: A Feasibility Study Using a DNP-Modified Autologous Ovarian Tumor Cell Vaccine as Therapy in Ovarian Cancer Patients After Relapse:
AVAX Technologies6 sites in 1 country34 target enrollmentStarted: June 1, 2008Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 34
- Locations
- 6
- Primary Endpoint
- Cell-mediated immunity to autologous tumor cells
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Screening Phase
- •Stage III or IV adenocarcinoma of ovary
- •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
Outcomes
Primary Outcomes
Cell-mediated immunity to autologous tumor cells
Time Frame: 3 months
Secondary Outcomes
- Safety(9 months)
Investigators
Study Sites (6)
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