Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004086
Status:
UNKNOWN
Last Update Posted:
2009-06-09
First Post:
1999-12-10
Brief Title:
Radiolabeled Monoclonal Antibody Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory B-Cell Cancer
Sponsor:
Garden State Cancer Center at the Center for Molecular Medicine and Immunology
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Trial of a Combined Regimen of Chemotherapy and 90Y-Labeled Humanized LL2 Anti-CD22 Antibody With Peripheral Stem Cell Rescue for the Treatment of Relapsed or Refractory Non-Hodgkins Lymphoma
Status:
UNKNOWN
Status Verified Date:
2001-12
Last Known Status:
ACTIVE_NOT_RECRUITING
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 either kill them or deliver cancer killing substances to them without harming normal cells Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells
PURPOSE Phase I trial to study the effectiveness of radiolabeled monoclonal antibody plus combination chemotherapy and peripheral stem cell transplantation in treating patients who have recurrent or B-cell cancer
PURPOSE Phase I trial to study the effectiveness of radiolabeled monoclonal antibody plus combination chemotherapy and peripheral stem cell transplantation in treating patients who have recurrent or B-cell cancer
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose and dose limiting toxicity of yttrium Y 90 humanized anti-CD22 LL2 Y90 MOAB hLL2 in combination with salvage chemotherapy and autologous peripheral blood stem cell rescue in patients with recurrent or refractory B-cell malignancies II Study the effect of chemotherapy on the uptake of Y90 MOAB hLL2 into tumor sites and normal organs by pretherapy imaging using indium In 111 humanized LL2 and intratherapy imaging III Determine the extent and duration of tumor response in patients receiving this regimen
OUTLINE This is a dose escalation study of yttrium Y 90 humanized anti-CD22 monoclonal antibody LL2 Y90 MOAB hLL2 Patients receive filgrastim G-CSF subcutaneously daily for 5 days and undergo harvest of peripheral blood stem cells PBSC on 2 or more consecutive days If an adequate number of CD34 cells are not harvested autologous bone marrow may be used Chemotherapy-induced mobilization with filgrastim allowed Patients undergo pretherapy imaging with indium In 111 humanized LL2 In111 hLL2 for up to 40 minutes on day -7 Patients receive Y90 MOAB hLL2 for up to 40 minutes on day 0 plus In111 hLL2 followed by Y90 MOAB hLL2 alone on day 3 Patients receive ifosfamide IV over 1 hour cisplatin IV over 2 hours and cytarabine IV over 2 hours on days 1 and 4 Oral etoposide is given daily on days 1-7 PBSC or bone marrow is reinfused on days 9-14 depending on MOAB clearance 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 3 or 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 Approximately 15-24 patients will be accrued for this study within 2-25 years
OUTLINE This is a dose escalation study of yttrium Y 90 humanized anti-CD22 monoclonal antibody LL2 Y90 MOAB hLL2 Patients receive filgrastim G-CSF subcutaneously daily for 5 days and undergo harvest of peripheral blood stem cells PBSC on 2 or more consecutive days If an adequate number of CD34 cells are not harvested autologous bone marrow may be used Chemotherapy-induced mobilization with filgrastim allowed Patients undergo pretherapy imaging with indium In 111 humanized LL2 In111 hLL2 for up to 40 minutes on day -7 Patients receive Y90 MOAB hLL2 for up to 40 minutes on day 0 plus In111 hLL2 followed by Y90 MOAB hLL2 alone on day 3 Patients receive ifosfamide IV over 1 hour cisplatin IV over 2 hours and cytarabine IV over 2 hours on days 1 and 4 Oral etoposide is given daily on days 1-7 PBSC or bone marrow is reinfused on days 9-14 depending on MOAB clearance 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 3 or 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 Approximately 15-24 patients will be accrued for this study within 2-25 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-V99-1569 | None | None | None |
| CMMI-C-037C-97 | None | None | None |