Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00079339
Status:
COMPLETED
Last Update Posted:
2014-05-15
First Post:
2004-03-08
Brief Title:
Tipifarnib and Radiation Therapy in Treating Young Patients With Brainstem Glioma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Trial of R115777 and XRT in Pediatric Patients With Newly Diagnosed Non-Disseminated Intrinsic Diffuse Brainstem Gliomas
Status:
COMPLETED
Status Verified Date:
2012-12
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:
Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth Radiation therapy uses high-energy x-rays to damage tumor cells Tipifarnib may make tumor cells more sensitive to radiation therapy Combining tipifarnib with radiation therapy may kill more tumor cells This phase III trial is studying the side effects and best dose of tipifarnib to see how well it works when given together with radiation therapy in treating young patients with newly diagnosed brain stem glioma Phase I closed to accrual as of 11906
Detailed Description:
PRIMARY OBJECTIVES
I To estimate the maximum tolerated dose MTD of R115777 administered concurrently with radiation therapy to pediatric patients with non-disseminated diffuse intrinsic brainstem gliomas who are not receiving enzyme-inducing anti-convulsant drugs EIACD
II To assess the efficacy of R115777 treatment in combination with radiation therapy for patients with non-disseminated diffuse intrinsic pontine gliomas as measured by progression-free survival and survival distributions
SECONDARY OBJECTIVES
I To characterize toxicities associated with R115777 treatment in combination with and post radiation therapy
II To characterize radiographic changes in brainstem gliomas treated with radiation and R115777 using MRI perfusion and diffusion imaging and PET scans
OUTLINE This is a phase I closed to accrual as of 11906 multicenter dose-escalation study of tipifarnib followed by a phase II safety and efficacy study
PHASE I Patients undergo radiotherapy 5 days a week for 6 weeks Beginning 0-2 days before radiotherapy patients receive oral tipifarnib twice daily until the completion of radiotherapy Beginning 2 weeks after the completion of radiotherapy patients receive oral tipifarnib twice daily in weeks 1-3 Treatment repeats every 4 weeks for up to 24 additional courses total of 26 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of tipifarnib during radiotherapy until the maximum tolerated dose is determined The MTD is defined as the dose level preceding that at which 2 of 6 patients experience dose-limiting toxicity
PHASE II Patients undergo radiotherapy and receive tipifarnib at the MTD as in phase I closed to accrual as of 11906 Treatment continues for up to 24 months 26 courses in the absence of disease progression or unacceptable toxicity
FOLLOW-UP
Phase I Participants contributing only to the phase I part are followed for 90 days after completion of therapy Adverse events that have not resolved within 90 days after stopping treatment will be followed until resolution
Phase II Participants in the phase I part treated at the MTD or participants in the phase II part are followed until the earliest of death or three years after starting treatment
PROJECTED ACCRUAL A total of 3-55 patients 3-18 patients for phase I closed to accrual as of 11906 and a total of 40 patients for phase II including 6 patients treated in the dose-finding portion of phase I closed to accrual as of 11906 will be accrued for this study within 23 years
I To estimate the maximum tolerated dose MTD of R115777 administered concurrently with radiation therapy to pediatric patients with non-disseminated diffuse intrinsic brainstem gliomas who are not receiving enzyme-inducing anti-convulsant drugs EIACD
II To assess the efficacy of R115777 treatment in combination with radiation therapy for patients with non-disseminated diffuse intrinsic pontine gliomas as measured by progression-free survival and survival distributions
SECONDARY OBJECTIVES
I To characterize toxicities associated with R115777 treatment in combination with and post radiation therapy
II To characterize radiographic changes in brainstem gliomas treated with radiation and R115777 using MRI perfusion and diffusion imaging and PET scans
OUTLINE This is a phase I closed to accrual as of 11906 multicenter dose-escalation study of tipifarnib followed by a phase II safety and efficacy study
PHASE I Patients undergo radiotherapy 5 days a week for 6 weeks Beginning 0-2 days before radiotherapy patients receive oral tipifarnib twice daily until the completion of radiotherapy Beginning 2 weeks after the completion of radiotherapy patients receive oral tipifarnib twice daily in weeks 1-3 Treatment repeats every 4 weeks for up to 24 additional courses total of 26 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of tipifarnib during radiotherapy until the maximum tolerated dose is determined The MTD is defined as the dose level preceding that at which 2 of 6 patients experience dose-limiting toxicity
PHASE II Patients undergo radiotherapy and receive tipifarnib at the MTD as in phase I closed to accrual as of 11906 Treatment continues for up to 24 months 26 courses in the absence of disease progression or unacceptable toxicity
FOLLOW-UP
Phase I Participants contributing only to the phase I part are followed for 90 days after completion of therapy Adverse events that have not resolved within 90 days after stopping treatment will be followed until resolution
Phase II Participants in the phase I part treated at the MTD or participants in the phase II part are followed until the earliest of death or three years after starting treatment
PROJECTED ACCRUAL A total of 3-55 patients 3-18 patients for phase I closed to accrual as of 11906 and a total of 40 patients for phase II including 6 patients treated in the dose-finding portion of phase I closed to accrual as of 11906 will be accrued for this study within 23 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 |
|---|---|---|---|
| U01CA081457 | NIH | CTEP | httpsreporternihgovquickSearchU01CA081457 |
| NCI-2012-03021 | REGISTRY | None | None |
| PBTC-014 | OTHER | None | None |
| PBTC-014 | OTHER | None | None |