Temozolomide in Treating Patients With Recurrent Glioblastoma Multiforme or Other Malignant Glioma

Study Overview
=================
Brief Summary
-----------------
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. PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with recurrent glioblastoma multiforme or other malignant glioma.

Detailed Description
-----------------
OBJECTIVES: Primary Determine the progression-free survival rate at 6 months in patients with recurrent glioblastoma multiforme or other malignant glioma treated with temozolomide. Secondary Determine the overall survival of patients treated with this drug. OUTLINE: Patients receive oral temozolomide once daily in the absence of disease progression or unacceptable toxicity. Blood samples are collected at baseline and every 2 months for 2 years for evaluation of markers of neo-angiogenesis. Samples are analyzed by protein expression, reverse-transcriptase PCR, ELISA, and western blot. (Samples are no longer being collected and tested as of 1/12/09)

Official Title
-----------------
A Phase II Trial of Continuous Low-Dose Temozolomide for Patients With Recurrent Malignant Glioma

Conditions
-----------------
Brain and Central Nervous System Tumors

Intervention / Treatment
-----------------
* Drug: temozolomide
* Genetic: protein expression analysis
* Genetic: reverse transcriptase-polymerase chain reaction
* Other: diagnostic laboratory biomarker analysis
* Other: immunoenzyme technique


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Pathologically diagnosed glioblastoma multiforme or other malignant glioma Recurrent disease Must have received prior temozolomide PATIENT CHARACTERISTICS: Karnofsky performance status 60-100% Granulocyte count ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ SGOT ≤ 2.5 times upper limit of normal (ULN) Creatinine ≤ 2 times ULN Bilirubin ≤ 2 times ULN No other active malignancy except for cervical carcinoma in situ or basal cell carcinoma of the skin No serious medical or psychiatric illness that, in the opinion of the investigator, would preclude study treatment No medical condition that precludes swallowing pills Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: See Disease Characteristics Recovered from all prior therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Temozolomide<br>Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death. | Drug: temozolomide<br> <br> Genetic: protein expression analysis<br> <br> Genetic: reverse transcriptase-polymerase chain reaction<br> <br> Other: diagnostic laboratory biomarker analysis<br> <br> Other: immunoenzyme technique<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival (PFS) Rate at 6 Months | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | All patients will have their tumor measurements recorded at baseline and at the time of each MRI scan. Lesions must be measured in two dimensions. The dose of gadolinium must be held constant from scan to scan. Macdonald criteria will be used for assessment of tumor response. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recurrent adult brain tumor, adult giant cell glioblastoma, adult glioblastoma, adult gliosarcoma, adult anaplastic astrocytoma, adult diffuse astrocytoma, adult pilocytic astrocytoma, adult subependymal giant cell astrocytoma, adult anaplastic ependymoma, adult ependymoma, adult myxopapillary ependymoma, adult subependymoma, adult anaplastic oligodendroglioma, adult oligodendroglioma, adult brain stem glioma, adult mixed glioma, adult pineal gland astrocytoma