Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003386
Status:
TERMINATED
Last Update Posted:
2013-04-11
First Post:
1999-11-01
Brief Title:
Vaccine Therapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
Treatment of Ovarian Carcinoma With DNP-Modified Autologous Tumor Vaccine
Status:
TERMINATED
Status Verified Date:
2008-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GOG-9802 | None | None | None |