Ovarian Cancer Clinical Trial
Official title:
Treatment of Ovarian Carcinoma With DNP-Modified Autologous Tumor Vaccine
RATIONALE: Vaccines made from tumor tissue may make the body build an immune response and
kill tumor cells.
PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients
who have stage III or stage IV ovarian epithelial cancer.
OBJECTIVES: I. Determine whether patients with surgically debulked ovarian epithelial cancer
develop delayed-type hypersensitivity to dinitrophenyl-modified autologous tumor vaccine.
II. Assess the toxic effects of this regimen in these patients. III. Determine the
feasibility of conducting a group wide vaccine study.
OUTLINE: Patients undergo a standard debulking procedure with the tumor tissue being sent to
Thomas Jefferson University. Patients then receive six courses of combination chemotherapy
consisting of either paclitaxel and cisplatin or paclitaxel and carboplatin. Vaccine therapy
must commence within 4-12 weeks of completion of chemotherapy. Patients are tested for
delayed-type hypersensitivity (DTH) on day -7. Cyclophosphamide IV is administered on day 0.
Dinitrophenyl (DNP)-modified autologous ovarian epithelial cell vaccine and BCG adjuvant are
injected once a week beginning on day 3 and continuing for 6 weeks. DTH testing is repeated
at week 8. Booster vaccine injections are administered at 6 and 12 months if patient is
disease free. Patients are followed every 3 months for 2 years, every 6 months for 3 years,
and then annually thereafter.
PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study.
;
Primary Purpose: Treatment
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