Status:
COMPLETED
High-Dose Methotrexate and Leucovorin in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Lead Sponsor:
Eastern Cooperative Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
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-d...
Detailed Description
OBJECTIVES: Primary * Determine the response in patients with newly diagnosed glioblastoma multiforme treated with high-dose methotrexate and leucovorin calcium. Secondary * Determine the acute to...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed glioblastoma multiforme (GBM)
- Supratentorial grade IV disease
- Measurable and contrast-enhancing disease ≥ 1 cm 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
Exclusion
Key Trial Info
Start Date :
July 12 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00082797
Start Date
July 12 2005
Last Update
June 15 2023
Active Locations (65)
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1
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60507
2
St. Joseph Medical Center
Bloomington, Illinois, United States, 61701
3
Graham Hospital
Canton, Illinois, United States, 61520
4
Memorial Hospital
Carthage, Illinois, United States, 62321