Radiation Therapy in Treating Patients With Glioblastoma
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|ClinicalTrials.gov Identifier: NCT00019058|
Recruitment Status : Completed
First Posted : April 5, 2004
Last Update Posted : April 29, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: chemotherapy Drug: hydroxyurea Drug: pentoxifylline Radiation: radiation therapy||Phase 1|
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 (e.g., 0.4-2.0 mM/24 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 0.4-2.0 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Official Title:||A PHASE I STUDY OF COMBINED RADIATION RESPONSE MODIFIERS EMPLOYING HYDROXYUREA AND PENTOXIFYLLINE FOR TREATMENT OF GLIOBLASTOMA|
|Study Start Date :||April 1995|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00019058
|United States, Maryland|
|Radiation Oncology Branch|
|Bethesda, Maryland, United States, 20892|
|Study Chair:||Brian G. Fuller, MD||NCI - Radiation Oncology Branch; ROB|