Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00293410
Status:
COMPLETED
Last Update Posted:
2010-05-06
First Post:
2006-02-16
Brief Title:
Clofarabine and Cyclophosphamide in Treating Patients With Relapsed or Refractory Acute Leukemia Chronic Myelogenous Leukemia or Myeloproliferative Disorders
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Phase I Dose-Escalation Trial of Clofarabine Followed by Escalating Doses of Fractionated Cyclophosphamide in Adults and Children With Relapsed or Refractory Acute Leukemias
Status:
COMPLETED
Status Verified Date:
2010-05
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 clofarabine and cyclophosphamide work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more cancer cells
PURPOSE This phase I trial is studying the side effects and best dose of clofarabine and cyclophosphamide in treating patients with relapsed or refractory acute leukemia chronic myelogenous leukemia or myeloproliferative disorders
PURPOSE This phase I trial is studying the side effects and best dose of clofarabine and cyclophosphamide in treating patients with relapsed or refractory acute leukemia chronic myelogenous leukemia or myeloproliferative disorders
Detailed Description:
OBJECTIVES
Primary
Determine the feasibility and tolerability of administering clofarabine and fractionated cyclophosphamide in patients with relapsed or refractory acute leukemia chronic myelogenous leukemia or high-risk myeloproliferative disorders
Determine the maximum tolerated dose of clofarabine and fractionated cyclophosphamide in these patients
Determine the toxic effects of these drugs in these patients
Secondary
Obtain preliminary data of biologic and pharmacodynamic effects of this regimen on marrow and circulating leukemic blasts in these patients
OUTLINE This is a dose-escalation study Patients are stratified according to age adult vs child
Patients receive cyclophosphamide IV over 2 hours on day 0 Patients then receive clofarabine IV over 2 hours and cyclophosphamide IV over 2 hours on days 1-3 and 8-10 Treatment with clofarabine and cyclophosphamide repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of clofarabine and cyclophosphamide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity At least 10 patients are treated at the MTD
After completion of study treatment patients are followed periodically for 1 year
PROJECTED ACCRUAL A total of 70 patients will be accrued for this study
Primary
Determine the feasibility and tolerability of administering clofarabine and fractionated cyclophosphamide in patients with relapsed or refractory acute leukemia chronic myelogenous leukemia or high-risk myeloproliferative disorders
Determine the maximum tolerated dose of clofarabine and fractionated cyclophosphamide in these patients
Determine the toxic effects of these drugs in these patients
Secondary
Obtain preliminary data of biologic and pharmacodynamic effects of this regimen on marrow and circulating leukemic blasts in these patients
OUTLINE This is a dose-escalation study Patients are stratified according to age adult vs child
Patients receive cyclophosphamide IV over 2 hours on day 0 Patients then receive clofarabine IV over 2 hours and cyclophosphamide IV over 2 hours on days 1-3 and 8-10 Treatment with clofarabine and cyclophosphamide repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of clofarabine and cyclophosphamide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity At least 10 patients are treated at the MTD
After completion of study treatment patients are followed periodically for 1 year
PROJECTED ACCRUAL A total of 70 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 |
|---|---|---|---|
| JHOC-00000845 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006973 |
| P30CA006973 | NIH | None | None |
| JHOC-J0561 | None | None | None |