Vaccine Therapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer
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.
|Ovarian Cancer||Biological: BCG vaccine Biological: autologous tumor cell vaccine Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: paclitaxel Other: dinitrophenyl Procedure: surgical procedure||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Treatment of Ovarian Carcinoma With DNP-Modified Autologous Tumor Vaccine|
|Study Start Date:||July 1999|
|Primary Completion Date:||April 2001 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003386
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|Study Chair:||David Berd, MD||Sidney Kimmel Cancer Center at Thomas Jefferson University|