Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019058
Status:
COMPLETED
Last Update Posted:
2015-04-29
First Post:
2001-07-11
Brief Title:
Radiation Therapy in Treating Patients With Glioblastoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A PHASE I STUDY OF COMBINED RADIATION RESPONSE MODIFIERS EMPLOYING HYDROXYUREA AND PENTOXIFYLLINE FOR TREATMENT OF GLIOBLASTOMA
Status:
COMPLETED
Status Verified Date:
2001-12
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:
RATIONALE Radiation therapy uses high-energy x-rays to damage tumor cells Drugs such as pentoxifylline and hydroxyurea may make tumor cells more sensitive to radiation therapy
PURPOSE Phase I trial to study the effectiveness of radiation therapy plus pentoxifylline and hydroxyurea in treating patients who have high-grade astrocytoma or glioblastoma
PURPOSE Phase I trial to study the effectiveness of radiation therapy plus pentoxifylline and hydroxyurea in treating patients who have high-grade astrocytoma or glioblastoma
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of pentoxifylline administered with hydroxyurea during a course of cranial radiotherapy in patients with glioblastoma multiforme II Determine the toxicity of this regimen in these patients III Measure PTX levels in plasma and CSF in order to assess whether therapeutic drug exposures eg 04-20 mM24 hours can be achieved with an acceptable level of toxicity IV Assess the local control of glioblastoma in patients treated with this regimen V Determine the response of surrounding normal brain in patients treated with this regimen VI Determine the survival of patients treated with this regimen
OUTLINE This is a dose escalation study of pentoxifylline PTX Patients receive hydroxyurea HU and PTX IV continuously 5 days a week concurrently with cranial radiotherapy twice daily 5 days a week for 4 weeks in the absence of disease progression or unacceptable toxicity The first cohort of 3 patients is treated with radiotherapy and HU alone Subsequent cohorts of 3-6 patients receive HU and radiotherapy plus escalating doses of PTX until the maximum tolerated dose of PTX is determined or serum or CSF drug concentrations reach 04-20 mM in 6 consecutive patients with acceptable toxicity The MTD is defined as the dose immediately preceding that at which 2 of 6 patients experience dose-limiting toxicity Patients are followed at 1 week at 1 and 3 months every 3 months for 2 years and then every 4 months for 5 years
PROJECTED ACCRUAL A maximum of 24-34 patients will be accrued for this study
OUTLINE This is a dose escalation study of pentoxifylline PTX Patients receive hydroxyurea HU and PTX IV continuously 5 days a week concurrently with cranial radiotherapy twice daily 5 days a week for 4 weeks in the absence of disease progression or unacceptable toxicity The first cohort of 3 patients is treated with radiotherapy and HU alone Subsequent cohorts of 3-6 patients receive HU and radiotherapy plus escalating doses of PTX until the maximum tolerated dose of PTX is determined or serum or CSF drug concentrations reach 04-20 mM in 6 consecutive patients with acceptable toxicity The MTD is defined as the dose immediately preceding that at which 2 of 6 patients experience dose-limiting toxicity Patients are followed at 1 week at 1 and 3 months every 3 months for 2 years and then every 4 months for 5 years
PROJECTED ACCRUAL A maximum of 24-34 patients will be accrued for this study
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 |
|---|---|---|---|
| NCI-95-C-0069 | None | None | None |
| NCI-95-C-0069A | None | None | None |
| NCI-95-C-0069D | None | None | None |