Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004107
Status:
COMPLETED
Last Update Posted:
2011-06-22
First Post:
1999-12-10
Brief Title:
Radiolabeled Monoclonal Antibody Therapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Lymphoma or Waldenstroms Macroglobulinemia
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 of Non-Hodgkins Lymphoma With High-Dose 90Y-Labeled Humanized LL2 Anti-CD-22 Antibody and Peripheral Blood Stem Cell Rescue
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 cancer cells and deliver cancer-killing substances to them without harming normal cells Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by monoclonal antibody therapy used to kill cancer cells
PURPOSE Phase III trial to study the effectiveness of radiolabeled monoclonal antibody therapy plus peripheral stem cell transplantation in treating patients who have lymphoma or Waldenstroms macroglobulinemia that has not responded to previous therapy
PURPOSE Phase III trial to study the effectiveness of radiolabeled monoclonal antibody therapy plus peripheral stem cell transplantation in treating patients who have lymphoma or Waldenstroms macroglobulinemia that has not responded to previous therapy
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose and dose limiting toxicity of radioimmunotherapy using high dose yttrium Y 90 humanized anti-CD22 monoclonal antibody LL2 Y90 MOAB hLL2 followed by autologous peripheral blood stem cell transplantation in patients with B cell lymphomas or Waldenstroms macroglobulinemia II Determine the organ and tumor dosimetry for comparison to clinical measurement of toxicity and antitumor responses in these patients III Determine magnitude and duration of human anti-humanized LL2 antibody HAhLL2 or anti-DOTA response in these patients IV Evaluate the extent and duration of antitumor response to this regimen in these patients
OUTLINE This is a dose escalation multicenter study Patients are stratified according to prior treatment high dose chemotherapy with transplantation vs low dose chemotherapy with radioimmunotherapy RAIT vs low dose chemotherapy without RAIT Patients receive filgrastim G-CSF subcutaneously SC daily for 5 days and undergo harvest of peripheral blood stem cells PBSC If an adequate number of CD34 cells are not harvested autologous bone marrow may be used Patients undergo pretherapy imaging with indium In 111 monoclonal antibody MN-14 In111-MN-14 IV on day -7 If at least 1 tumor site is targeted patients receive high dose yttrium Y 90 humanized anti-CD22 monoclonal antibody LL2 Y90 MOAB hLL2 IV for up to 50 minutes on day 0 PBSC or bone marrow is reinfused approximately 7-14 days following infusion of Y90 MOAB hLL2 Patients also receive G-CSF SC daily until 3 days after blood counts have recovered Cohorts of 3-6 patients receive escalating doses of Y90 MOAB hLL2 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity Patients are followed weekly for 2 months monthly for 6 months and then every 6 months for 5 years
PROJECTED ACCRUAL A total of 12-24 patients will be accrued for this study within 2 years
OUTLINE This is a dose escalation multicenter study Patients are stratified according to prior treatment high dose chemotherapy with transplantation vs low dose chemotherapy with radioimmunotherapy RAIT vs low dose chemotherapy without RAIT Patients receive filgrastim G-CSF subcutaneously SC daily for 5 days and undergo harvest of peripheral blood stem cells PBSC If an adequate number of CD34 cells are not harvested autologous bone marrow may be used Patients undergo pretherapy imaging with indium In 111 monoclonal antibody MN-14 In111-MN-14 IV on day -7 If at least 1 tumor site is targeted patients receive high dose yttrium Y 90 humanized anti-CD22 monoclonal antibody LL2 Y90 MOAB hLL2 IV for up to 50 minutes on day 0 PBSC or bone marrow is reinfused approximately 7-14 days following infusion of Y90 MOAB hLL2 Patients also receive G-CSF SC daily until 3 days after blood counts have recovered Cohorts of 3-6 patients receive escalating doses of Y90 MOAB hLL2 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity Patients are followed weekly for 2 months monthly for 6 months and then every 6 months for 5 years
PROJECTED ACCRUAL A total of 12-24 patients will be accrued for this study within 2 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-H99-0040 | US NIH GrantContract | None | httpsreporternihgovquickSearchR01CA067026 |
| UPCC-1499 | None | None | None |
| R01CA067026 | NIH | None | None |
| CMMI-C-037B-97 | None | None | None |