Temozolomide and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Anaplastic Astrocytoma

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-13

Study Completion Date

2014-11-25

Brief Summary

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RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving chemotherapy together with radiation therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of temozolomide when given together with radiation therapy in treating patients with newly diagnosed glioblastoma multiforme or anaplastic astrocytoma.

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Detailed Description

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OBJECTIVES:

Primary

* To determine the maximum tolerated dose of temozolomide when given in combination with hypofractionated intensity-modulated conformal stereotactic radiotherapy in patients with newly diagnosed de novo glioblastoma multiforme or anaplastic astrocytoma.

Secondary

* To determine the time to neuroradiological evidence of tumor recurrence or progression in patients treated with this regimen.
* To determine the survival time of patients treated with this regimen.
* To determine the time spent in a Karnofsky performance status of 60-100%.

OUTLINE: This is a dose-escalation study of temozolomide.

Beginning 1-3 weeks following surgery or biopsy, patients receive oral temozolomide once daily for 5 weeks. Beginning 1 week after starting temozolomide, patients also undergo hypofractionated intensity-modulated conformal stereotactic radiotherapy once daily 5 days a week for 3 weeks.

After completion of study treatment, patients are followed at 1 month, 2 months, and 3 months, and then every 3 months thereafter.

Conditions

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Glioblastoma Multiforme/Anaplastic Astrocytoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hypofractionation Radiotherapy+Temozolomide

Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.

Group Type EXPERIMENTAL

temozolomide

Intervention Type DRUG

Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.

Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment

Hypofractionated radiation therapy

Intervention Type RADIATION

Patients will undergo HIMRT

Intensity-modulated radiation therapy

Intervention Type RADIATION

Patients undergo HIMRT

Interventions

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temozolomide

Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.

Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment

Intervention Type DRUG

Hypofractionated radiation therapy

Patients will undergo HIMRT

Intervention Type RADIATION

Intensity-modulated radiation therapy

Patients undergo HIMRT

Intervention Type RADIATION

Other Intervention Names

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Temodar Temodal IMRT

Eligibility Criteria

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Inclusion Criteria

* Patients who have De novo glioblastoma multiforme, anaplastic astrocytoma, anaplastic oligodendrogliomas, mixed anaplastic oligoastrocytomas, gliosarcoma of the Brain, not involving the brain stem or optics chiasm, diagnosed following biopsy or tumor removal.
* Age \> 18 years
* Given written consent
* Adequate bone marrow reserve(hemoglobin \> 10 grams, Absolute neutrophil count \> 1500 / mm3, platelets \> 100,000/ mm3)
* Normal renal function(BUN \< 24 mg/dL, Creatinine \< 1.3 mg/dL)
* Normal liver function(Total Bilirubin \< 1.5 mg/dL, SGPT/ALT \< 60 U/L)

Exclusion Criteria

* Have a Karnofsky score of \< 60 \[Appendix B\] or age \< 18 years.
* Prior chemotherapy and/or radiotherapy of their glioblastomamultiforme, anaplastic astrocytoma, anaplastic oligodendrogliomas, mixed anaplastic oligoastrocytomas, gliosarcoma.
* Tumors located in the brainstem or optic chiasm.
* Prior radiation therapy to the brain
* Prior chemotherapy within the past 6 weeks.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No