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High-Dose Methotrexate and Le...

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

Last Updated: 2023-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-12

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Brain and Central Nervous System Tumors

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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leucovorin calcium

Intervention Type DRUG

methotrexate

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Eastern Cooperative Oncology Group

Principal Investigators

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Stuart A. Grossman, MD

Role: STUDY_CHAIR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Jana Portnow, MD

Role: STUDY_CHAIR

City of Hope Comprehensive Cancer Center

Locations

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Rush-Copley Cancer Care Center

Aurora, Illinois, United States

Site Status

St. Joseph Medical Center

Bloomington, Illinois, United States

Site Status

Graham Hospital

Canton, Illinois, United States

Site Status