Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075634
Status:
COMPLETED
Last Update Posted:
2013-09-30
First Post:
2004-01-09
Brief Title:
Decitabine Doxorubicin and Cyclophosphamide in Treating Children With Relapsed or Refractory Solid Tumors or Neuroblastoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Decitabine NSC 127716 IND 50733 in Combination With Doxorubicin and Cyclophosphamide in the Treatment of Relapsed or Refractory Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-09
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:
This phase I trial is studying the side effects and best dose of decitabine when given together with doxorubicin and cyclophosphamide in treating children with relapsed or refractory solid tumors or neuroblastoma Drugs used in chemotherapy such as decitabine doxorubicin and cyclophosphamide work in different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose of decitabine in combination with doxorubicin and cyclophosphamide in children with relapsed or refractory solid tumors or neuroblastoma
II Determine the toxic effects of this regimen in these patients III Determine whether decitabine induces tumor caspase-8 demethylation and expression in these patients
SECONDARY OBJECTIVES
I Determine the pharmacokinetics of low-dose decitabine in these patients II Determine the biological and clinical response in patients treated with this regimen
III Compare patterns of peripheral blood gene expression using gene expression profiling in patients before and after treatment with decitabine
OUTLINE This is a multicenter dose-escalation study of decitabine
PART A solid tumor patients Patients receive decitabine IV over 1 hour on days 0-6 and doxorubicin IV over 15 minutes and cyclophosphamide IV over 1 hour on day 7 Patients then receive filgrastim G-CSF subcutaneously SC beginning on day 8 and continuing until blood counts recover OR pegfilgrastim SC once on day 8 or 9 Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of decitabine 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
NOTE For patients 45 kg
PART B neuroblastoma patients Once the MTD is determined for part A patients are treated as in part A at the MTD
Patients are followed at 30 days
I Determine the maximum tolerated dose of decitabine in combination with doxorubicin and cyclophosphamide in children with relapsed or refractory solid tumors or neuroblastoma
II Determine the toxic effects of this regimen in these patients III Determine whether decitabine induces tumor caspase-8 demethylation and expression in these patients
SECONDARY OBJECTIVES
I Determine the pharmacokinetics of low-dose decitabine in these patients II Determine the biological and clinical response in patients treated with this regimen
III Compare patterns of peripheral blood gene expression using gene expression profiling in patients before and after treatment with decitabine
OUTLINE This is a multicenter dose-escalation study of decitabine
PART A solid tumor patients Patients receive decitabine IV over 1 hour on days 0-6 and doxorubicin IV over 15 minutes and cyclophosphamide IV over 1 hour on day 7 Patients then receive filgrastim G-CSF subcutaneously SC beginning on day 8 and continuing until blood counts recover OR pegfilgrastim SC once on day 8 or 9 Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of decitabine 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
NOTE For patients 45 kg
PART B neuroblastoma patients Once the MTD is determined for part A patients are treated as in part A at the MTD
Patients are followed at 30 days
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 |
|---|---|---|---|
| U01CA097452 | NIH | CTEP | httpsreporternihgovquickSearchU01CA097452 |
| NCI-2012-01807 | REGISTRY | None | None |
| CDR0000347393 | None | None | None |
| COG-ADVL0215 | None | None | None |
| ADVL0215 | OTHER | None | None |
| ADVL0215 | OTHER | None | None |