NCT00003386

Vaccine Therapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer

Treatment of Ovarian Carcinoma With DNP-Modified Autologous Tumor Vaccine

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Gynecologic Oncology Group · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
BIOLOGICAL	BCG vaccine
BIOLOGICAL	autologous tumor cell vaccine
DRUG	carboplatin
DRUG	cisplatin
DRUG	cyclophosphamide
DRUG	paclitaxel
OTHER	dinitrophenyl
PROCEDURE	surgical procedure

Timeline

• Start date: 1999-07-01
• Primary completion: 2001-04-01
• First posted: 2004-04-23
• Last updated: 2013-04-11

Locations

60 sites across 2 countries: United States, Canada