Completed

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

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What is being tested

leucovorin calcium

+ methotrexate
Drug
Who is being recruted

Brain and Central Nervous System Tumors

From 18 to 120 Years
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: July 2005

Summary

Principal SponsorEastern Cooperative Oncology Group
Last updated: June 15, 2023
Sourced from a government-validated database.Claim as a partner
Study start date: July 12, 2005Actual date on which the first participant was enrolled.

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. PURPOSE: This phase II trial is studying how well giving high-dose methotrexate together with leucovorin works in treating patients with newly diagnosed glioblastoma multiforme. OBJECTIVES: Primary * Determine the response in patients with newly diagnosed glioblastoma multiforme treated with high-dose methotrexate and leucovorin calcium. Secondary * Determine the acute toxicity of this regimen in these patients. * Determine the duration of survival of patients treated with this regimen. OUTLINE: This is a multicenter study. 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 then receive standard radiotherapy with or without chemotherapy. Patients with disease progression proceed to standard radiotherapy with or without chemotherapy upon stopping methotrexate therapy. 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.

Official TitleA Phase II Study Of Systemic High-Dose Methotrexate For The Treatment Of Glioblastoma Multiforme In Newly Diagnosed Patients With Measurable Disease 
Principal SponsorEastern Cooperative Oncology Group
Last updated: June 15, 2023
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
36 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 120 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Brain and Central Nervous System Tumors
Criteria

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


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 65 locations
Suspended
Rush-Copley Cancer Care CenterAurora, United StatesSee the location
Suspended
St. Joseph Medical CenterBloomington, United States
Suspended
Graham HospitalCanton, United States
Suspended
Memorial HospitalCarthage, United States

Completed65 Study Centers