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 After Relapse

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