Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004177
Status:
COMPLETED
Last Update Posted:
2011-06-22
First Post:
2000-01-21
Brief Title:
Radiolabeled Monoclonal Antibody Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory or Recurrent Ovarian Epithelial Cancer
Sponsor:
Garden State Cancer Center at the Center for Molecular Medicine and Immunology
Organization:
Garden State Cancer Center at the Center for Molecular Medicine and Immunology
Study Overview
Official Title:
Phase III Radioimmunotherapy With High-Dose 90Y-Labeled Humanized MN-14 in Advanced Ovarian Cancer Using Autologous Peripheral Blood Stem Cell Rescue PBSCR to Control Myelotoxicity
Status:
COMPLETED
Status Verified Date:
2011-06
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 Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by therapy used to kill tumor cells
PURPOSE Phase III trial to study the effectiveness of radiolabeled monoclonal antibody plus peripheral stem cell transplantation in treating patients who have refractory or recurrent ovarian epithelial cancer
PURPOSE Phase III trial to study the effectiveness of radiolabeled monoclonal antibody plus peripheral stem cell transplantation in treating patients who have refractory or recurrent ovarian epithelial cancer
Detailed Description:
OBJECTIVES I Determine the normal organ and tumor dosimetry with yttrium Y 90 monoclonal antibody MN-14 using indium In 111 monoclonal antibody MN-14 as pretherapy in patients with advanced ovarian epithelial cancer II Evaluate the extent and duration of antitumor response in these patients on this regimen
OUTLINE This is a dose escalation study of yttrium Y 90 monoclonal antibody MN-14 90Y hMN-14 Patients receive filgrastim G-CSF subcutaneously SQ on days -17 to -13 followed by leukapheresis on days -14 to -12 If an adequate number of CD34 cells are not harvested bone marrow is also collected Patients receive pretherapy targeting consisting of indium In 111 monoclonal antibody MN-14 over 30 minutes on day -7 At least 1 confirmed tumor site must be targeted Patients receive 90Y hMN-14 IV over 30-45 minutes on day 0 PBSC is reinfused within 7 to 14 days after 90 hMN-14 administration Patients receive G-CSF SQ or IV until blood counts recover Cohorts of 3-6 patients receive escalating doses of 90Y hMN-14 until the maximum tolerated dose MTD is determined The MTD is defined as either the dose at which no more than 1 of 6 patients experiences dose limiting toxicity or the threshold radiation doses to lungs kidney and liver are reached Patients are followed weekly for 1 month every 2 weeks for 2 months monthly for 3 months every 3 months for 2 years and then every 6 months for 5 years
PROJECTED ACCRUAL Approximately 48-51 patients will be accrued for this study within 5 years
OUTLINE This is a dose escalation study of yttrium Y 90 monoclonal antibody MN-14 90Y hMN-14 Patients receive filgrastim G-CSF subcutaneously SQ on days -17 to -13 followed by leukapheresis on days -14 to -12 If an adequate number of CD34 cells are not harvested bone marrow is also collected Patients receive pretherapy targeting consisting of indium In 111 monoclonal antibody MN-14 over 30 minutes on day -7 At least 1 confirmed tumor site must be targeted Patients receive 90Y hMN-14 IV over 30-45 minutes on day 0 PBSC is reinfused within 7 to 14 days after 90 hMN-14 administration Patients receive G-CSF SQ or IV until blood counts recover Cohorts of 3-6 patients receive escalating doses of 90Y hMN-14 until the maximum tolerated dose MTD is determined The MTD is defined as either the dose at which no more than 1 of 6 patients experiences dose limiting toxicity or the threshold radiation doses to lungs kidney and liver are reached Patients are followed weekly for 1 month every 2 weeks for 2 months monthly for 3 months every 3 months for 2 years and then every 6 months for 5 years
PROJECTED ACCRUAL Approximately 48-51 patients will be accrued for this study within 5 years
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 |
|---|---|---|---|
| NCI-V99-1570 | US NIH GrantContract | None | httpsreporternihgovquickSearchR03CA077146 |
| R03CA077146 | NIH | None | None |
| CMMI-C-039A-98 | None | None | None |
| NCI-H99-0044 | None | None | None |