Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002865
Status:
COMPLETED
Last Update Posted:
2018-08-10
First Post:
1999-11-01
Brief Title:
High-Intensity Brief-Duration Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphocytic Leukemia
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
HIGH INTENSITY BRIEF DURATION CHEMOTHERAPY FOR RELAPSED OR REFRACTORY ALL A PHASE II STUDY OF A MULTIDRUG REGIMEN
Status:
COMPLETED
Status Verified Date:
2018-08
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of high-intensity brief-duration chemotherapy in treating patients with relapsed or refractory acute lymphocytic leukemia
PURPOSE Phase II trial to study the effectiveness of high-intensity brief-duration chemotherapy in treating patients with relapsed or refractory acute lymphocytic leukemia
Detailed Description:
OBJECTIVES I Determine the complete response rate to high-intensity brief-duration chemotherapy with cyclophosphamide methotrexate vincristine doxorubicin and dexamethasone followed by ifosfamide methotrexate vincristine cytarabine etoposide and dexamethasone in patients with relapsed or refractory acute lymphocytic leukemia ALL II Determine the toxic effects of these regimens in these patients
OUTLINE All patients receive up to six alternating courses every 3-4 weeks of two chemotherapy regimens cyclophosphamide oral dexamethasone methotrexate with leucovorin rescue vincristine and doxorubicin over 5 days and ifosfamidemesna oral dexamethasone methotrexate with leucovorin rescue vincristine cytarabine and etoposide over 5 days G-CSF is given following each course until recovery of the neutrophil count All patients receive triple intrathecal chemotherapy on day 1 Patients with CNS disease receive intrathecal therapy twice weekly until the CSF is clear then weekly for 4 weeks and monthly for 1 year those who have not received prior CNS irradiation also receive whole-brain radiotherapy Patients are followed monthly for 6 months every 3 months for 18 months every 6 months for 2 years then annually
PROJECTED ACCRUAL A total of 37 evaluable patients will be accrued if at least 4 of the first 17 patients respond
OUTLINE All patients receive up to six alternating courses every 3-4 weeks of two chemotherapy regimens cyclophosphamide oral dexamethasone methotrexate with leucovorin rescue vincristine and doxorubicin over 5 days and ifosfamidemesna oral dexamethasone methotrexate with leucovorin rescue vincristine cytarabine and etoposide over 5 days G-CSF is given following each course until recovery of the neutrophil count All patients receive triple intrathecal chemotherapy on day 1 Patients with CNS disease receive intrathecal therapy twice weekly until the CSF is clear then weekly for 4 weeks and monthly for 1 year those who have not received prior CNS irradiation also receive whole-brain radiotherapy Patients are followed monthly for 6 months every 3 months for 18 months every 6 months for 2 years then annually
PROJECTED ACCRUAL A total of 37 evaluable patients will be accrued if at least 4 of the first 17 patients respond
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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-V96-1062 | None | None | None |
| CCCWFU-21195 | None | None | None |