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

Phase 2

Terminated

• Conditions: Ovarian Cancer

• Registration Number: NCT00003386
• Lead Sponsor: Gynecologic Oncology Group

Brief 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.

Study Timeline

• Study Start: 1999-07
• Study First Submitted: 1999-11-01
• Primary Completion: 2001-04
• Study First Submitted QC: 2004-04-22
• Study First Posted: 2004-04-23
• Status Verified: 2008-12
• Last Update Submitted: 2013-04-10
• Last Update Posted: 2013-04-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (60)

University of Alabama Comprehensive Cancer Center; 🇺🇸 Birmingham, Alabama, United States

CCOP - Greater Phoenix; 🇺🇸 Phoenix, Arizona, United States

Jonsson Comprehensive Cancer Center, UCLA; 🇺🇸 Los Angeles, California, United States

Community Hospital of Los Gatos; 🇺🇸 Los Gatos, California, United States

Chao Family Comprehensive Cancer Center; 🇺🇸 Orange, California, United States

University of Colorado Cancer Center; 🇺🇸 Denver, Colorado, United States

Walter Reed Army Medical Center; 🇺🇸 Washington, District of Columbia, United States

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States

CCOP - Atlanta Regional; 🇺🇸 Atlanta, Georgia, United States

MBCCOP - Hawaii; 🇺🇸 Honolulu, Hawaii, United States

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