Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00107471
Status:
TERMINATED
Last Update Posted:
2013-12-10
First Post:
2005-04-05
Brief Title:
Topotecan G-CSF and Radiation Therapy in Treating Young Patients With Newly Diagnosed Brain Stem Glioma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Phase III Study of Topotecan With G-CSF and Radiation Therapy in Children With Malignant Intrinsic Pontine Brainstem Gliomas of Childhood
Status:
TERMINATED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The unpromising experience of the French group with topotecan given at a dosage of 04 mgm2day over 30 mins win 1 hr of radiation Cancer 2005 104 2792
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 such as topotecan work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Colony-stimulating factors such as G-CSF may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy Radiation therapy uses high-energy x-rays to kill tumor cells Topotecan may make tumor cells more sensitive to radiation therapy Giving topotecan and G-CSF together with radiation therapy may be an effective treatment for brain stem glioma
PURPOSE This phase III trial is studying the side effects and best dose of topotecan when given together with G-CSF and radiation therapy and to see how well they work in treating young patients with newly diagnosed brain stem glioma
PURPOSE This phase III trial is studying the side effects and best dose of topotecan when given together with G-CSF and radiation therapy and to see how well they work in treating young patients with newly diagnosed brain stem glioma
Detailed Description:
OBJECTIVES
Primary
Determine the feasibility of escalating the dose of topotecan when administered with filgrastim G-CSF and radiotherapy in terms of increasing the topotecan dose 25-50 above the maximum tolerated dose MTD determined in a prior phase I study in young patients with newly diagnosed malignant intrinsic pontine brain stem glioma Phase I
Determine the dose-limiting toxic effects of topotecan in these patients Phase I
Determine the 1-year event-free survival and overall survival of patients treated with this regimen at the MTD of topotecan determined in phase I Phase II
Determine the toxicity of this regimen in these patients Phase II
Secondary
Determine the pharmacokinetics of this regimen in these patients
OUTLINE This is a multicenter phase I dose-escalation study of topotecan followed by a phase II study
Phase I Patients receive topotecan IV over 30 minutes followed by radiotherapy once daily 5 days a week for 6-7 weeks During chemoradiotherapy patients also receive filgrastim G-CSF IV or subcutaneously daily if needed until blood counts recover Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 out of 6 patients experience dose-limiting toxicity
Phase II Patients receive topotecan at the MTD determined in phase I G-CSF and radiotherapy as in phase I
After completion of study treatment patients are followed within 2 weeks every 3 months for 15 years every 6 months for 15 years and then annually until disease relapse
PROJECTED ACCRUAL A total of 3-72 patients 3-12 for phase I and 60 for phase II will be accrued for this study within approximately 3 years
Primary
Determine the feasibility of escalating the dose of topotecan when administered with filgrastim G-CSF and radiotherapy in terms of increasing the topotecan dose 25-50 above the maximum tolerated dose MTD determined in a prior phase I study in young patients with newly diagnosed malignant intrinsic pontine brain stem glioma Phase I
Determine the dose-limiting toxic effects of topotecan in these patients Phase I
Determine the 1-year event-free survival and overall survival of patients treated with this regimen at the MTD of topotecan determined in phase I Phase II
Determine the toxicity of this regimen in these patients Phase II
Secondary
Determine the pharmacokinetics of this regimen in these patients
OUTLINE This is a multicenter phase I dose-escalation study of topotecan followed by a phase II study
Phase I Patients receive topotecan IV over 30 minutes followed by radiotherapy once daily 5 days a week for 6-7 weeks During chemoradiotherapy patients also receive filgrastim G-CSF IV or subcutaneously daily if needed until blood counts recover Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 out of 6 patients experience dose-limiting toxicity
Phase II Patients receive topotecan at the MTD determined in phase I G-CSF and radiotherapy as in phase I
After completion of study treatment patients are followed within 2 weeks every 3 months for 15 years every 6 months for 15 years and then annually until disease relapse
PROJECTED ACCRUAL A total of 3-72 patients 3-12 for phase I and 60 for phase II will be accrued for this study within approximately 3 years
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 |
|---|---|---|---|
| COG-ACNS0224 | OTHER | Childrens Oncology Group | None |
| CDR0000417842 | OTHER | None | None |