Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003837
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
1999-11-01
Brief Title:
506U78 in Treating Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Compound 506U78 NSC 686673 in Patients With Relapsed or Refractory T-Cell ALL or T-Cell Lymphoblastic Lymphoma
Status:
COMPLETED
Status Verified Date:
2005-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 Clinical trial to study the effectiveness of 506U78 in treating patients who have relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma
PURPOSE Clinical trial to study the effectiveness of 506U78 in treating patients who have relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma
Detailed Description:
OBJECTIVES
Provide an investigational agent 506U78 to physicians for the management of individual patients with relapsed or refractory T-cell acute lymphoblastic lymphocytic leukemia or T-cell lymphoblastic lymphoma who are not candidates for entry onto ongoing research clinical trials of higher priority
Evaluate the toxic effects of 506U78 when administered as a 2 hour IV infusion 3 days a week every 21 days in these patients
Evaluate the antitumor efficacy of this regimen in terms of rate of complete responses in these patients
OUTLINE Patients receive 506U78 over 2 hours on days 1 3 and 5 Treatment repeats every 21 days for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression
Patients are followed every 3 months for one year and then every 6 months until death
PROJECTED ACCRUAL A minimum of 25 patients will be accrued for this study
Provide an investigational agent 506U78 to physicians for the management of individual patients with relapsed or refractory T-cell acute lymphoblastic lymphocytic leukemia or T-cell lymphoblastic lymphoma who are not candidates for entry onto ongoing research clinical trials of higher priority
Evaluate the toxic effects of 506U78 when administered as a 2 hour IV infusion 3 days a week every 21 days in these patients
Evaluate the antitumor efficacy of this regimen in terms of rate of complete responses in these patients
OUTLINE Patients receive 506U78 over 2 hours on days 1 3 and 5 Treatment repeats every 21 days for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression
Patients are followed every 3 months for one year and then every 6 months until death
PROJECTED ACCRUAL A minimum of 25 patients will be accrued for this study
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 |
|---|---|---|---|
| CTEP-TRC-9701 | None | None | None |
| CWRU-TRC-1499 | None | None | None |