Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004084
Status:
COMPLETED
Last Update Posted:
2011-06-22
First Post:
1999-12-10
Brief Title:
Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Lymphoma or Leukemia
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 Radiolabeled Humanized Immu-LL2 Treatment With 90Y-hLL2 IgG
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
PURPOSE Phase III trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients who have lymphoma or leukemia that has not responded to previous chemotherapy
PURPOSE Phase III trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients who have lymphoma or leukemia that has not responded to previous chemotherapy
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose and dose limiting toxicity of yttrium Y 90-labeled humanized anti-CD22 monoclonal antibody LL290Y-hLL2 IgG in patients with B-cell malignancies II Determine the pharmacokinetics and biodistribution of indium In 111 humanized LL2 111In-hLL2 IgG in these patients III Evaluate the immunogenicity of repeated injections of 90Y-hLL2 IgG in these patients IV Determine whether 90Y-hLL2 IgG versus indium In 131 humanized LL2 IgG has a therapeutic advantage based on organ and tumor dosimetry obtained with 111In-hLL2 IgG
OUTLINE This is a dose escalation study Patients are stratified into risk groups high vs low Patients receive pretherapy imaging with indium In 111 humanized LL2 IgG IV for up to 30 minutes on days -7 to 0 Patients receive yttrium Y 90-labeled humanized anti-CD22 monoclonal antibody LL2 90Y-hLL2-IgG IV for up to 30 minutes on day 0 Cohorts of 3-6 patients receive escalating doses of 90Y-hLL2-IgG until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding the dose at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity Patients are followed every 2 weeks for 1 month monthly for 2 months and then every 6 months thereafter
PROJECTED ACCRUAL A total of 18-24 patients will be accrued for this study within 1-2 years
OUTLINE This is a dose escalation study Patients are stratified into risk groups high vs low Patients receive pretherapy imaging with indium In 111 humanized LL2 IgG IV for up to 30 minutes on days -7 to 0 Patients receive yttrium Y 90-labeled humanized anti-CD22 monoclonal antibody LL2 90Y-hLL2-IgG IV for up to 30 minutes on day 0 Cohorts of 3-6 patients receive escalating doses of 90Y-hLL2-IgG until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding the dose at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity Patients are followed every 2 weeks for 1 month monthly for 2 months and then every 6 months thereafter
PROJECTED ACCRUAL A total of 18-24 patients will be accrued for this study within 1-2 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 |
|---|---|---|---|
| R01CA067026 | NIH | None | None |
| CMMI-C-037A-97 | None | None | None |
| NCI-H99-0041 | None | None | None |
| NCI-V99-1567 | US NIH GrantContract | None | httpsreporternihgovquickSearchR01CA067026 |