Trials Sponsors Conditions Drugs Pricing

Conditions

Brain and Central Nervous System Tumors

Keywords

adult glioblastomaadult giant cell glioblastomaadult gliosarcoma

Outcome Measures

Primary Outcomes (1)

Response rate (complete and partial)

Secondary Outcomes (1)

Frequency of toxicity

Interventions

leucovorin calciumDrug

methotrexateDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 120 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

Eastern Cooperative Oncology Group
Research networklead
National Cancer Institute (NCI)
NIHcollaborator

Study Sites (65)

Rush-Copley Cancer Care Center

Aurora, Illinois, 60507, United States

St. Joseph Medical Center

Bloomington, Illinois, 61701, United States

Graham Hospital

Canton, Illinois, 61520, United States

Memorial Hospital

Carthage, Illinois, 62321, United States

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Hematology and Oncology Associates

Chicago, Illinois, 60611, United States

University of Illinois Cancer Center

Chicago, Illinois, 60612-7243, United States

MeSH Terms

Conditions

Central Nervous System NeoplasmsGlioblastomaGliosarcoma

Interventions

LeucovorinMethotrexate

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesAstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and Embryonal

Study Officials

Stuart A. Grossman, MD
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
STUDY CHAIR
Jana Portnow, MD
City of Hope Medical Center
STUDY CHAIR

Study Design

Study Type: interventional
Phase: phase 2
Masking: NONE
Purpose: TREATMENT
Sponsor Type: NETWORK

Study Record Dates

First Submitted

May 14, 2004

First Posted

May 19, 2004

Study Start

July 12, 2005

Actual (reported)

Primary Completion

May 2007

Actual (reported)

High-Dose Methotrexate and Leucovorin in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (65)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (65)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record

Locations