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