Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003370
Status:
COMPLETED
Last Update Posted:
2013-02-05
First Post:
1999-11-01
Brief Title:
Irofulven in Treating Children With Recurrent or Refractory Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Trial of MGI 114 in Children With Solid Tumors A Pediatric Oncology Group Phase I Cooperative Agreement Study
Status:
COMPLETED
Status Verified Date:
2006-05
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 irofulven in treating children with recurrent or refractory solid tumors Drugs used in chemotherapy use different ways to stop tumor cells so they stop growing or die
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose and dose limiting toxicity of 6-hydroxymethylacylfulvene MGI-114 in pediatric patients with recurrent or refractory solid tumors
II Determine the incidence and severity of other toxic effects of MGI-114 III Determine a safe and tolerable dose of MGI-114 to be used in phase II studies
IV Determine the pharmacokinetics of MGI-114 in these patients V Determine preliminary evidence of antitumor activity of MGI-114 against recurrent or refractory pediatric solid tumors
OUTLINE This is a dose escalation study If the dose limiting toxicity is myelosuppression in stratum 1 then stratum 1 is closed and stratum 2 opens
Stratum 2 consists of the following patients receiving no more than 2 prior chemotherapy regimens patients who have not received prior central axis radiation or bone marrow transplantation and patients with no known bone marrow involvement Patients receive intravenous 6-hydroxymethylacylfulvene over 10 minutes daily for 5 days The course is repeated every 28 days unless disease progression or unacceptable toxic effects are observed Patients with stable or responding disease may receive up to 1 year of therapy If dose limiting toxicity occurs in 2 of 6 patients at a given dose level then dose escalation ceases and the next lower dose is declared the maximum tolerated dose Dose escalation will not occur until all patients within a cohort have been observed for 28 days from day 1 of therapy Patients are followed until death
I Determine the maximum tolerated dose and dose limiting toxicity of 6-hydroxymethylacylfulvene MGI-114 in pediatric patients with recurrent or refractory solid tumors
II Determine the incidence and severity of other toxic effects of MGI-114 III Determine a safe and tolerable dose of MGI-114 to be used in phase II studies
IV Determine the pharmacokinetics of MGI-114 in these patients V Determine preliminary evidence of antitumor activity of MGI-114 against recurrent or refractory pediatric solid tumors
OUTLINE This is a dose escalation study If the dose limiting toxicity is myelosuppression in stratum 1 then stratum 1 is closed and stratum 2 opens
Stratum 2 consists of the following patients receiving no more than 2 prior chemotherapy regimens patients who have not received prior central axis radiation or bone marrow transplantation and patients with no known bone marrow involvement Patients receive intravenous 6-hydroxymethylacylfulvene over 10 minutes daily for 5 days The course is repeated every 28 days unless disease progression or unacceptable toxic effects are observed Patients with stable or responding disease may receive up to 1 year of therapy If dose limiting toxicity occurs in 2 of 6 patients at a given dose level then dose escalation ceases and the next lower dose is declared the maximum tolerated dose Dose escalation will not occur until all patients within a cohort have been observed for 28 days from day 1 of therapy Patients are followed until death
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 |
|---|---|---|---|
| CDR0000066359 | REGISTRY | PDQ Physician Data Query | None |
| POG-9772 | None | None | None |