Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003625
Status:
COMPLETED
Last Update Posted:
2014-07-28
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Newly Diagnosed Brain Stem Glioma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Vincristine Etoposide and Cyclosporine A in Concert With Standard Dose Radiation Therapy in Diffuse Intrinsic Brain Stem Glioma - A Phase I Study of Dose Escalation of Vincristine
Status:
COMPLETED
Status Verified Date:
2014-07
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 Radiation therapy uses high-energy x-rays to damage tumor cells Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients with newly diagnosed brain stem glioma
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients with newly diagnosed brain stem glioma
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose and dose limiting toxicity of vincristine given as an IV push dose in combination with continuous infusion cyclosporine and oral etoposide concurrent with and prior to radiotherapy in children with newly diagnosed primary intrinsic brain stem glioma II Determine the incidence and severity of other toxicities of vincristine in this regimen in these patients III Determine a safe and tolerable dose of vincristine under these conditions to be used in phase II studies IV Seek preliminary evidence of antitumor activity in this setting in these patients
OUTLINE This is dose escalation study of vincristine Patients receive radiotherapy daily for 6 weeks with concurrent induction chemotherapy Induction chemotherapy consists of vincristine IV push weekly for 6 weeks oral etoposide daily on days 1-21 and 29-49 and cyclosporine IV over 2 hours prior to vincristine followed by a continuous 36 hour infusion Cohorts of 3-6 patients receive escalating doses of vincristine If dose limiting toxicity DLT occurs in 2 or more of 3-6 patients the maximum tolerated dose MTD has been exceeded and the preceding dose is declared the MTD Maintenance therapy consists of 6 monthly courses of cyclosporine IV over 36 hours beginning on day 1 vincristine IV push on day 1 and oral etoposide daily for days 1-21 Patients are followed every 6 months for 4 years and then annually thereafter
PROJECTED ACCRUAL At least 6 patients will be accrued into this study at a rate of 12 patients per year
OUTLINE This is dose escalation study of vincristine Patients receive radiotherapy daily for 6 weeks with concurrent induction chemotherapy Induction chemotherapy consists of vincristine IV push weekly for 6 weeks oral etoposide daily on days 1-21 and 29-49 and cyclosporine IV over 2 hours prior to vincristine followed by a continuous 36 hour infusion Cohorts of 3-6 patients receive escalating doses of vincristine If dose limiting toxicity DLT occurs in 2 or more of 3-6 patients the maximum tolerated dose MTD has been exceeded and the preceding dose is declared the MTD Maintenance therapy consists of 6 monthly courses of cyclosporine IV over 36 hours beginning on day 1 vincristine IV push on day 1 and oral etoposide daily for days 1-21 Patients are followed every 6 months for 4 years and then annually thereafter
PROJECTED ACCRUAL At least 6 patients will be accrued into this study at a rate of 12 patients per year
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 |
|---|---|---|---|
| CDR0000066706 | None | None | None |
| POG-9879 | None | None | None |