Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077558
Status:
COMPLETED
Last Update Posted:
2010-03-10
First Post:
2004-02-10
Brief Title:
3-AP Followed By Fludarabine In Treating Patients With Relapsed or Refractory Acute or Chronic Leukemia or High-Risk Myelodysplastic Syndrome
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
A Phase I Trial Of Sequential Administration Of Triapine 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone Followed By Fludarabine In Adults With Relapsed And Refractory Leukemias And Myelodysplasias
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 Drugs used in chemotherapy such as fludarabine work in different ways to stop cancer cells from dividing so they stop growing or die 3-AP may help fludarabine kill more cancer cells by making them more sensitive to the drug
PURPOSE This phase I trial is studying the side effects and best dose of fludarabine when given together with 3-AP in treating patients with relapsed or refractory acute leukemia chronic leukemia or high-risk myelodysplastic syndrome
PURPOSE This phase I trial is studying the side effects and best dose of fludarabine when given together with 3-AP in treating patients with relapsed or refractory acute leukemia chronic leukemia or high-risk myelodysplastic syndrome
Detailed Description:
OBJECTIVES
Determine the feasibility and tolerability of 3-AP Triapine followed by fludarabine in patients with relapsed or refractory acute or chronic leukemia or high-risk myelodysplastic syndromes
Determine the toxic effects of this regimen in these patients
Determine the maximum tolerated dose of this regimen in these patients
OUTLINE This is a multicenter dose-escalation study of fludarabine Patients are stratified according to disease acute leukemias and myelodysplastic syndromes MDS vs chronic lymphocytic leukemia and prolymphocytic leukemia Patients are assigned to 1 of 2 treatment groups
Group 1 chronic lymphocytic leukemia or prolymphocytic leukemia Patients receive 3-AP Triapine IV over 4 hours and fludarabine IV over 30 minutes on days 1-5
Cohorts of 3-6 patients receive escalating doses of fludarabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined 10 additional patients are treated at that dose level
Group 2 acute leukemias or MDS Patients receive 3-AP IV continuously over 24 hours on day 1 Beginning within 4 hours after completion of 3-AP patients receive fludarabine IV over 30 minutes on days 2-6
In both groups treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 3-34 patients will be accrued for this study
Determine the feasibility and tolerability of 3-AP Triapine followed by fludarabine in patients with relapsed or refractory acute or chronic leukemia or high-risk myelodysplastic syndromes
Determine the toxic effects of this regimen in these patients
Determine the maximum tolerated dose of this regimen in these patients
OUTLINE This is a multicenter dose-escalation study of fludarabine Patients are stratified according to disease acute leukemias and myelodysplastic syndromes MDS vs chronic lymphocytic leukemia and prolymphocytic leukemia Patients are assigned to 1 of 2 treatment groups
Group 1 chronic lymphocytic leukemia or prolymphocytic leukemia Patients receive 3-AP Triapine IV over 4 hours and fludarabine IV over 30 minutes on days 1-5
Cohorts of 3-6 patients receive escalating doses of fludarabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined 10 additional patients are treated at that dose level
Group 2 acute leukemias or MDS Patients receive 3-AP IV continuously over 24 hours on day 1 Beginning within 4 hours after completion of 3-AP patients receive fludarabine IV over 30 minutes on days 2-6
In both groups treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 3-34 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 |
|---|---|---|---|
| NCI-6255 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006973 |
| U01CA070095 | NIH | None | None |
| P30CA006973 | NIH | None | None |
| JHOC-J0357 | None | None | None |