Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002693
Status:
COMPLETED
Last Update Posted:
2011-08-03
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Recurrent Acute Leukemia
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
PHASE I STUDY OF CONTINUOUS INFUSION CARBOPLATIN AND TOPOTECAN IN THE TREATMENT OF RELAPSED ACUTE LEUKEMIA AND BLAST CRISIS CHRONIC MYELOGENOUS LEUKEMIA
Status:
COMPLETED
Status Verified Date:
2011-08
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 Combining more than one drug may kill more cancer cells
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy with carboplatin and topotecan in treating patients with chronic myelogenous leukemia or recurrent acute leukemia
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy with carboplatin and topotecan in treating patients with chronic myelogenous leukemia or recurrent acute leukemia
Detailed Description:
OBJECTIVES
Estimate the maximum tolerated dose of carboplatin plus topotecan given as a 5-day continuous infusion in patients with recurrent acute lymphocytic or myeloid leukemia or accelerated or blastic phase chronic myelogenous leukemia
Assess the toxicity of this regimen in these patients
Gather preliminary information on the activity of this regimen in these patients
Examine the pharmacokinetics of topotecan when administered concurrently with carboplatin
OUTLINE This is a dose escalation study of topotecan Patients are stratified according to prior bone marrow transplant BMT yes vs no
Induction Patients receive carboplatin and topotecan IV 3 times a day on days 1-5 Patients may also receive filgrastim G-CSF beginning on day 7 or 14 Retreatment is based on results of marrow exam on day 10-14 Patients with less than 5 blasts undergo a second marrow exam upon blood count recovery or on day 26-30 whichever is earlier Patients with at least 5 blasts after day 21 receive one more course in the absence of unacceptable toxicity and at the discretion of the investigator Patients with no greater than 5 blasts begin G-CSF if blood counts are not recovered then proceed to consolidation
Cohorts of 1-6 patients receive escalating doses of topotecan until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of up to 6 patients experience dose limiting toxicity Patients with prior BMT will not be entered at any level until 3-6 patients with no prior BMT tolerate that level
Consolidation begins around day 42 of last Induction course Patients with ALLAML in complete remission CR or CML in chronic phase receive 2 additional courses same doses 6-8 weeks apart
Patients experiencing a relapse after CR lasting at least 6 months may receive additional treatment
PROJECTED ACCRUAL A total of 15-20 patients without and 2-20 patients with prior bone marrow transfer will be accrued for this study over 2-25 years
Estimate the maximum tolerated dose of carboplatin plus topotecan given as a 5-day continuous infusion in patients with recurrent acute lymphocytic or myeloid leukemia or accelerated or blastic phase chronic myelogenous leukemia
Assess the toxicity of this regimen in these patients
Gather preliminary information on the activity of this regimen in these patients
Examine the pharmacokinetics of topotecan when administered concurrently with carboplatin
OUTLINE This is a dose escalation study of topotecan Patients are stratified according to prior bone marrow transplant BMT yes vs no
Induction Patients receive carboplatin and topotecan IV 3 times a day on days 1-5 Patients may also receive filgrastim G-CSF beginning on day 7 or 14 Retreatment is based on results of marrow exam on day 10-14 Patients with less than 5 blasts undergo a second marrow exam upon blood count recovery or on day 26-30 whichever is earlier Patients with at least 5 blasts after day 21 receive one more course in the absence of unacceptable toxicity and at the discretion of the investigator Patients with no greater than 5 blasts begin G-CSF if blood counts are not recovered then proceed to consolidation
Cohorts of 1-6 patients receive escalating doses of topotecan until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of up to 6 patients experience dose limiting toxicity Patients with prior BMT will not be entered at any level until 3-6 patients with no prior BMT tolerate that level
Consolidation begins around day 42 of last Induction course Patients with ALLAML in complete remission CR or CML in chronic phase receive 2 additional courses same doses 6-8 weeks apart
Patients experiencing a relapse after CR lasting at least 6 months may receive additional treatment
PROJECTED ACCRUAL A total of 15-20 patients without and 2-20 patients with prior bone marrow transfer will be accrued for this study over 2-25 years
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 |
|---|---|---|---|
| 958101 | OTHER | Mayo Clinic Cancer Center | httpsreporternihgovquickSearchP30CA015083 |
| U01CA069912 | NIH | None | None |
| P30CA015083 | NIH | None | None |