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
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