Ignite Creation Date:
2024-05-05 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003288
Status:
COMPLETED
Last Update Posted:
2013-02-05
First Post:
1999-11-01
Brief Title:
Tirapazamine Plus Cyclophosphamide in Treating Children With Refractory Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Trial of Tirapazamine and Cyclophosphamide in Children With Refractory Solid Tumors
Status:
COMPLETED
Status Verified Date:
2000-04
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 tirapazamine plus cyclophosphamide in treating children who have refractory solid tumors Drugs used in chemotherapy use 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:
OBJECTIVES
I Determine the maximum tolerated dose and the dose limiting toxicity of tirapazamine when administered with cyclophosphamide as intravenous infusions to children with refractory solid tumors
II Determine the incidence and severity of other toxicities of tirapazamine and cyclophosphamide in these patients
III Determine a safe and tolerable dose of tirapazamine administered with cyclophosphamide for a phase II study for the same indications
IV Determine the pharmacokinetics of tirapazamine in children and adolescents receiving the combination of tirapazamine and cyclophosphamide
V Determine the preliminary evidence of antitumor activity of tirapazamine and cyclophosphamide
OUTLINE This is a dose escalation study
Patients receive tirapazamine by 2 hour intravenous infusion hours 0-2 followed 2 hours later by a 30 minute intravenous infusion of cyclophosphamide This course is repeated every 3 weeks in patients with partialcomplete response or stable disease for a maximum of 1 year Cohorts of 3-6 patients each are treated at each dose level of tirapazamine Dose escalation of tirapazamine occurs when 0 of 3 patients or 1 of 6 patients has experienced dose limiting toxicity DLT If DLT is experienced in 1 of 3 patients at a given dose level up to 3 additional patients are treated at that same dose level If none of the 3 additional patients at that dose level experiences DLT the dose is escalated If DLT is experienced in 1 or more of the additional 3 patients the maximum tolerated dose MTD has been exceeded and 3 patients are treated at the next lower dose level defined as the MTD A total of six patients are treated at the MTD If DLT is proved to be neutropenia patients must then also meet the additional eligibility criteria listed for stratum 2 If neutropenia continues to be the DLT in stratum 2 then additional patients receive subcutaneous filgrastim granulocyte colony-stimulating factor G-CSF beginning 24 hours after cyclophosphamide A second MTD may be determined for chemotherapy with G-CSF Patients are followed every 6 months for 4 years and then annually thereafter
I Determine the maximum tolerated dose and the dose limiting toxicity of tirapazamine when administered with cyclophosphamide as intravenous infusions to children with refractory solid tumors
II Determine the incidence and severity of other toxicities of tirapazamine and cyclophosphamide in these patients
III Determine a safe and tolerable dose of tirapazamine administered with cyclophosphamide for a phase II study for the same indications
IV Determine the pharmacokinetics of tirapazamine in children and adolescents receiving the combination of tirapazamine and cyclophosphamide
V Determine the preliminary evidence of antitumor activity of tirapazamine and cyclophosphamide
OUTLINE This is a dose escalation study
Patients receive tirapazamine by 2 hour intravenous infusion hours 0-2 followed 2 hours later by a 30 minute intravenous infusion of cyclophosphamide This course is repeated every 3 weeks in patients with partialcomplete response or stable disease for a maximum of 1 year Cohorts of 3-6 patients each are treated at each dose level of tirapazamine Dose escalation of tirapazamine occurs when 0 of 3 patients or 1 of 6 patients has experienced dose limiting toxicity DLT If DLT is experienced in 1 of 3 patients at a given dose level up to 3 additional patients are treated at that same dose level If none of the 3 additional patients at that dose level experiences DLT the dose is escalated If DLT is experienced in 1 or more of the additional 3 patients the maximum tolerated dose MTD has been exceeded and 3 patients are treated at the next lower dose level defined as the MTD A total of six patients are treated at the MTD If DLT is proved to be neutropenia patients must then also meet the additional eligibility criteria listed for stratum 2 If neutropenia continues to be the DLT in stratum 2 then additional patients receive subcutaneous filgrastim granulocyte colony-stimulating factor G-CSF beginning 24 hours after cyclophosphamide A second MTD may be determined for chemotherapy with G-CSF Patients are followed every 6 months for 4 years and then annually thereafter
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 |
|---|---|---|---|
| CDR0000066219 | REGISTRY | PDQ Physician Data Query | None |
| POG-9675 | None | None | None |