Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002912
Status:
COMPLETED
Last Update Posted:
2013-02-01
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Plus PSC-833 in Treating Children With Refractory or Relapsed Acute Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A PHASE I COOPERATIVE AGREEMENT PEDIATRIC TRIAL OF MITOXANTRONE ETOPOSIDE AND PSC-833 PSC-ME THERAPY IN PATIENTS WITH RELAPSED AND REFRACTORY ACUTE LEUKEMIA
Status:
COMPLETED
Status Verified Date:
2010-08
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:
Phase I trial to study the effectiveness of PSC-833 plus etoposide and mitoxantrone in treating children who have refractory or relapsed acute leukemia Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Some cancers become resistant to chemotherapy drugs Combining PSC-833 with chemotherapy may reduce resistance to the drug and allow more cancer cells to be killed
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose of PSC-833 in combination with mitoxantrone and etoposide in children with refractory or relapsed acute leukemia
II Determine the effects of PSC-833 on mitoxantrone and etoposide pharmacokinetics
III Quantify MDR1 gene expression and MDR1 P-glycoprotein expression and function in patient-derived leukemia cells
OUTLINE This is a dose escalation study of PSC-833
Patients undergo induction therapy consisting of etoposide IV and mitoxantrone IV on days 1-5 Patients then receive PSC-833 IV over 124 hours beginning on day 2 A second course is administered no sooner than 21 days from the start of the first course if the marrow is hypocellular after the first course Patients with persistent disease after 2 induction courses are removed from the study Patients receive a total of 3 courses of etoposidemitoxantrone Patients who achieve complete remission after 1 induction course receive 2 courses of etoposidemitoxantrone with PSC-833 as consolidation beginning within 4 weeks of attainment of complete remission Patients who achieve complete remission after 2 induction courses receive 1 course of etoposidemitoxantrone with PSC-833 as consolidation Cohorts of 3-6 patients receive escalating doses of PSC-833 until the maximum tolerated dose is determined Patients are followed every 6 months
I Determine the maximum tolerated dose of PSC-833 in combination with mitoxantrone and etoposide in children with refractory or relapsed acute leukemia
II Determine the effects of PSC-833 on mitoxantrone and etoposide pharmacokinetics
III Quantify MDR1 gene expression and MDR1 P-glycoprotein expression and function in patient-derived leukemia cells
OUTLINE This is a dose escalation study of PSC-833
Patients undergo induction therapy consisting of etoposide IV and mitoxantrone IV on days 1-5 Patients then receive PSC-833 IV over 124 hours beginning on day 2 A second course is administered no sooner than 21 days from the start of the first course if the marrow is hypocellular after the first course Patients with persistent disease after 2 induction courses are removed from the study Patients receive a total of 3 courses of etoposidemitoxantrone Patients who achieve complete remission after 1 induction course receive 2 courses of etoposidemitoxantrone with PSC-833 as consolidation beginning within 4 weeks of attainment of complete remission Patients who achieve complete remission after 2 induction courses receive 1 course of etoposidemitoxantrone with PSC-833 as consolidation Cohorts of 3-6 patients receive escalating doses of PSC-833 until the maximum tolerated dose is determined Patients are followed every 6 months
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 |
|---|---|---|---|
| CDR0000065285 | REGISTRY | PDQ Physician Data Query | None |
| POG-9423 | None | None | None |
| CCG-P9423 | None | None | None |