Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00462787
Status:
COMPLETED
Last Update Posted:
2013-11-14
First Post:
2007-04-18
Brief Title:
Combination Chemotherapy in Treating Young Patients With Relapsed or Refractory Acute Leukemia
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase I Dose Escalation Trial of Clofarabine in Addition to Topotecan Vinorelbine Thiotepa and Dexamethasone in Pediatric Patients With Relapsed or Refractory Acute Leukemia
Status:
COMPLETED
Status Verified Date:
2013-11
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 topotecan vinorelbine thiotepa and dexamethasone 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 when given together with topotecan vinorelbine thiotepa and dexamethasone in treating young patients with relapsed or refractory acute leukemia
PURPOSE This phase I trial is studying the side effects and best dose of clofarabine when given together with topotecan vinorelbine thiotepa and dexamethasone in treating young patients with relapsed or refractory acute leukemia
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of clofarabine when administered in combination with topotecan hydrochloride vinorelbine ditartrate thiotepa and dexamethasone in young patients with relapsed or refractory acute leukemia
Evaluate the antileukemic potential of this regimen in these patients
Evaluate the incidence and severity of treatment-related morbidity and mortality in patients treated with this regimen
Develop a new reinduction treatment regimen that will result in a patient clinical response with as little residual disease as possible to permit a bone marrow transplantation while in subsequent remission maintain the response long enough to identify an appropriate stem cell donor and permit the patient to undergo a stem cell transplantation free of infections and without vital organ dysfunction
OUTLINE This is a nonrandomized prospective dose-escalation study of clofarabine
Patients receive topotecan hydrochloride IV continuously over 120 hours on days 0-4 vinorelbine ditartrate over 6-10 minutes on days 0 7 and 14 thiotepa IV over 4 hours on day 2 clofarabine IV over 2 hours on days 3-7 and oral or IV dexamethasone 3 times daily on days 3 and 7-13 and then on day 3 only thereafter Patients also receive filgrastim G-CSF subcutaneously once daily beginning on day 8 and continuing until blood counts recover Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of clofarabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity OR the dose preceding that at which 2 of 3 patients experience dose-limiting toxicity At least 6 patients are treated at the MTD
After completion of study treatment patients are followed once a week for 4 weeks twice a month for 6 months and then once a month for 2 years
PROJECTED ACCRUAL A total of 23 patients will be accrued for this study
Determine the maximum tolerated dose of clofarabine when administered in combination with topotecan hydrochloride vinorelbine ditartrate thiotepa and dexamethasone in young patients with relapsed or refractory acute leukemia
Evaluate the antileukemic potential of this regimen in these patients
Evaluate the incidence and severity of treatment-related morbidity and mortality in patients treated with this regimen
Develop a new reinduction treatment regimen that will result in a patient clinical response with as little residual disease as possible to permit a bone marrow transplantation while in subsequent remission maintain the response long enough to identify an appropriate stem cell donor and permit the patient to undergo a stem cell transplantation free of infections and without vital organ dysfunction
OUTLINE This is a nonrandomized prospective dose-escalation study of clofarabine
Patients receive topotecan hydrochloride IV continuously over 120 hours on days 0-4 vinorelbine ditartrate over 6-10 minutes on days 0 7 and 14 thiotepa IV over 4 hours on day 2 clofarabine IV over 2 hours on days 3-7 and oral or IV dexamethasone 3 times daily on days 3 and 7-13 and then on day 3 only thereafter Patients also receive filgrastim G-CSF subcutaneously once daily beginning on day 8 and continuing until blood counts recover Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of clofarabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity OR the dose preceding that at which 2 of 3 patients experience dose-limiting toxicity At least 6 patients are treated at the MTD
After completion of study treatment patients are followed once a week for 4 weeks twice a month for 6 months and then once a month for 2 years
PROJECTED ACCRUAL A total of 23 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 |
|---|---|---|---|
| MSKCC-07012 | None | None | None |