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High-Dose Methotrexate and Leucovorin Followed By Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme



High-Dose Methotrexate and Leucovorin Followed By Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

For Condition: adult glioblastoma multiforme
Status: Not yet recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy such as methotrexate work in different ways to stop tumor cells from dividing so they stop growing or die. Leucovorin may decrease side effects caused by high-dose methotrexate. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining high-dose methotrexate with leucovorin followed by radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme.
Details: OBJECTIVES: Primary - Determine the response in patients with newly diagnosed glioblastoma multiforme treated with high-dose methotrexate and leucovorin calcium followed by radiotherapy. Secondary - Determine the toxicity of this regimen, in terms of cognitive impairment and leukoencephalopathy, in these patients. - Determine the time to disease progression and survival of patients treated with this regimen. OUTLINE: This is a multicenter study. - Chemotherapy: Patients receive high-dose methotrexate IV over 4 hours on day 1 and oral or IV leucovorin calcium every 6 hours beginning on day 2 and continuing until blood methotrexate levels are acceptable. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who develop disease progression during chemotherapy proceed directly to focal brain radiotherapy. All other patients proceed to focal brain radiotherapy after completion of chemotherapy. - Focal brain radiotherapy: Beginning approximately 3 weeks after the completion of chemotherapy, patients receive standard focal brain radiotherapy once daily, 5 days a week, for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed at 30 days and then every 2 months for up to 2 years. PROJECTED ACCRUAL: A total of 19-36 patients will be accrued for this study.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed glioblastoma multiforme (GBM) - Supratentorial grade IV disease - Measurable and contrast-enhancing disease by CT scan or MRI - No radiographic evidence of ascites or pleural effusion PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count 1,500/mm^3 - Platelet count 100,000/mm^3 Hepatic - SGOT 4.0 times upper limit of normal - Bilirubin 2.0 mg/dL Renal - Creatinine 2.0 mg/dL - Creatinine clearance 50 mL/min Cardiovascular - No uncontrolled hypertension - No unstable angina - No symptomatic congestive heart failure - No uncontrolled cardiac arrhythmia - No myocardial infarction within the past 6 months Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Able to achieve hydration - No diabetes insipidus - No known hypersensitivity to methotrexate or leucovorin calcium - No concurrent serious infection or medical illness that would preclude study participation - No other malignancy within the past 2 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy - No prior immunotherapy for GBM - No prior administration of any of the following biologic agents for GBM: - Immunotoxins - Immunoconjugates - Antisense therapy - Peptide receptor antagonists - Interferons - Interleukins - Tumor-infiltrating lymphocytes - Lymphokine-activated killer cells - Gene therapy - No concurrent prophylactic growth factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF]) Chemotherapy - No prior chemotherapy for GBM - No other concurrent chemotherapy Endocrine therapy - Prior glucocorticoid therapy allowed - No prior hormonal therapy for GBM - Patients must be maintained on a stable corticosteroid regimen for at least 1 week Radiotherapy - No prior cranial irradiation - No prior radiotherapy for GBM Surgery - Recovered from prior surgery Other - At least 1 week since prior treatment with any of the following: - Salicylates - Non-steroidal anti-inflammatory drugs - Sulfonamide medications - Vitamin C - No other concurrent investigational agents
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
StuartGrossman,  Study Chair,  Sidney Kimmel Cancer Center


Additional Information:
Study ID Numbers:  CDR0000360834;  ECOG-E1F02
Study Start Date: 
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00082797

Other Adult Glioblastoma Multiforme Studies:
1. Combination Chemotherapy for Patients With Brain Cancer

2. Gefitinib and Radiation Therapy in Treating Patients With Glioblastoma Multiforme

3. ZD 1839 in Treating Patients With Glioblastoma Multiforme in First Relapse

4. Phosphorus 32 in Treating Patients With Glioblastoma Multiforme

5. Motexafin Gadolinium Plus Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

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