Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006020
Status:
COMPLETED
Last Update Posted:
2015-03-06
First Post:
2000-07-05
Brief Title:
S0010 506U78 in Treating Patients With Recurrent or Refractory Acute Lymphocytic Leukemia
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Phase II Trial of 506U78 IND 52611 in Patients With Relapsed or Refractory Non T-cell Acute Lymphoblastic Leukemia ALL
Status:
COMPLETED
Status Verified Date:
2015-03
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 Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of 506U78 in treating patients who have recurrent or refractory acute lymphocytic leukemia
PURPOSE Phase II trial to study the effectiveness of 506U78 in treating patients who have recurrent or refractory acute lymphocytic leukemia
Detailed Description:
OBJECTIVES
Assess the complete remission rate in patients with recurrent or refractory non-T-cell acute lymphocytic leukemia when treated with 506U78
Determine the frequency and severity of toxic effects of this drug in these patients
OUTLINE This is a multicenter study
Patients receive 506U78 IV over 2 hours on days 1 3 and 5 Treatment continues every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every month for 6 months every 3 months for 1 year and then every 6 months for 35 years
PROJECTED ACCRUAL A total of 20-35 patients will be accrued for this study within 18 months
Assess the complete remission rate in patients with recurrent or refractory non-T-cell acute lymphocytic leukemia when treated with 506U78
Determine the frequency and severity of toxic effects of this drug in these patients
OUTLINE This is a multicenter study
Patients receive 506U78 IV over 2 hours on days 1 3 and 5 Treatment continues every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every month for 6 months every 3 months for 1 year and then every 6 months for 35 years
PROJECTED ACCRUAL A total of 20-35 patients will be accrued for this study within 18 months
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 |
|---|---|---|---|
| S0010 | OTHER | None | None |
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |