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

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