Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003870
Status:
COMPLETED
Last Update Posted:
2010-04-02
First Post:
1999-11-01
Brief Title:
Monoclonal Antibody Therapy Cyclophosphamide and Total-Body Irradiation Followed by Peripheral Stem Cell Transplantation in Treating Patients With Advanced Recurrent Acute Lymphocytic Leukemia
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Radiolabeled BC8 Anti-CD45 Antibody Combined With Cyclophosphamide and Total Body Irradiation Followed by HLA-matched Related or Unrelated Stem Cell Transplantation as Treatment for Advanced Acute Lymphocytic Leukemia
Status:
COMPLETED
Status Verified Date:
2010-03
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 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 Radiation therapy uses high-energy x-rays to damage cancer cells Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill cancer cells
PURPOSE Phase II trial to study the effectiveness of monoclonal antibody therapy cyclophosphamide and total-body irradiation followed by peripheral stem cell transplantation in treating patients who have advanced recurrent acute lymphocytic leukemia
PURPOSE Phase II trial to study the effectiveness of monoclonal antibody therapy cyclophosphamide and total-body irradiation followed by peripheral stem cell transplantation in treating patients who have advanced recurrent acute lymphocytic leukemia
Detailed Description:
OBJECTIVES I Assess the efficacy and toxicity of iodine I 131 monoclonal antibody BC8 cyclophosphamide and total body irradiation in patients with advanced acute lymphocytic leukemia who are receiving HLA matched related or unrelated bone marrow transplantation II Determine the maximum tolerated dose MTD of iodine I 131 monoclonal antibody BC8 in these patients III Estimate the MTD of radiation delivered by iodine I 131 monoclonal antibody BC8 to the marrow IV Study the influence of marrow cellularity level of antigen expression by leukemic cells and degree of antigen saturation by antibody on the biodistribution of iodine I 131 monoclonal antibody BC8 in these patients
OUTLINE This is a dose-escalation study All patients receive a test dose of iodine I 131 monoclonal antibody BC8 MOAB BC8 IV over several hours 6-14 days prior to the therapeutic dose Patients receive the therapeutic dose of iodine I 131 MOAB BC8 IV over several hours on day -11 total body irradiation over 30-40 minutes twice a day on days -6 to -4 and cyclophosphamide IV over 1 hour on days -3 and -2 Patients undergo allogenic bone marrow transplantation on day 0 Patients receive intrathecal methotrexate twice prior to transplantation and then every other week for 4 weeks beginning on day 32 posttransplant Cohorts of 4 patients receive escalating doses of iodine I 131 monoclonal antibody until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 4 patients experience dose-limiting toxicity Patients are followed for the first 100 days at 6 9 and 12 months every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 4 years
OUTLINE This is a dose-escalation study All patients receive a test dose of iodine I 131 monoclonal antibody BC8 MOAB BC8 IV over several hours 6-14 days prior to the therapeutic dose Patients receive the therapeutic dose of iodine I 131 MOAB BC8 IV over several hours on day -11 total body irradiation over 30-40 minutes twice a day on days -6 to -4 and cyclophosphamide IV over 1 hour on days -3 and -2 Patients undergo allogenic bone marrow transplantation on day 0 Patients receive intrathecal methotrexate twice prior to transplantation and then every other week for 4 weeks beginning on day 32 posttransplant Cohorts of 4 patients receive escalating doses of iodine I 131 monoclonal antibody until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 4 patients experience dose-limiting toxicity Patients are followed for the first 100 days at 6 9 and 12 months every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 4 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 |
|---|---|---|---|
| FHCRC-129800 | None | None | None |
| NCI-H99-0029 | None | None | None |
| CDR0000067034 | REGISTRY | PDQ | None |