Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005952
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2000-07-05
Brief Title:
Temozolomide Plus Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Malignant Glioma or Recurrent CNS or Other Solid Tumors
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
A Phase III Trial of Temodar in Pediatric Patients and Young Adults With High-Risk or Recurrent Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-02
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 tumor cells from dividing so they stop growing or die Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells
PURPOSE This phase III trial is studying the side effects and best dose of temozolomide when given with peripheral stem cell transplantation and to see how well they work in treating children with newly diagnosed malignant glioma or recurrent CNS tumors or other solid tumors
PURPOSE This phase III trial is studying the side effects and best dose of temozolomide when given with peripheral stem cell transplantation and to see how well they work in treating children with newly diagnosed malignant glioma or recurrent CNS tumors or other solid tumors
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of temozolomide in children with newly diagnosed malignant glioma or recurrent CNS or other solid tumors
Evaluate the toxicity of this treatment in these patients
Determine the activity of this treatment in these patients
OUTLINE This is a dose escalation study of temozolomide
Patients receive filgrastim G-CSF subcutaneously SQ or IV beginning on day -5 and continuing through at least day 3 Peripheral blood stem cells PBSC are collected on days 0 2 and 4 Patients then receive oral temozolomide daily for 5 consecutive days PBSC collections are reinfused 1 day after the last dose of temozolomide Patients also receive G-CSF beginning at the time of transplant and continuing until blood counts recover Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicities
Patients are followed every 3 months for 1-3 years then annually thereafter
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study over 12 months
Determine the maximum tolerated dose of temozolomide in children with newly diagnosed malignant glioma or recurrent CNS or other solid tumors
Evaluate the toxicity of this treatment in these patients
Determine the activity of this treatment in these patients
OUTLINE This is a dose escalation study of temozolomide
Patients receive filgrastim G-CSF subcutaneously SQ or IV beginning on day -5 and continuing through at least day 3 Peripheral blood stem cells PBSC are collected on days 0 2 and 4 Patients then receive oral temozolomide daily for 5 consecutive days PBSC collections are reinfused 1 day after the last dose of temozolomide Patients also receive G-CSF beginning at the time of transplant and continuing until blood counts recover Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicities
Patients are followed every 3 months for 1-3 years then annually thereafter
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study over 12 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 |
|---|---|---|---|
| CDR0000067932 | OTHER | NCI | None |
| DUMC-1735-04-9R5 | None | None | None |
| DUMC-1735-02-9R3 | None | None | None |
| DUMC-1735-01-9R2 | None | None | None |
| DUMC-1833-99-10 | None | None | None |
| NCI-G00-1796 | None | None | None |