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High-Dose Methotrexate and Leucovorin in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00082797
  Purpose

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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: leucovorin calcium
Drug: methotrexate
Phase II

MedlinePlus related topics: Cancer
Drug Information available for: Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Methotrexate Calcium gluconate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study Of Systemic High-Dose Methotrexate For The Treatment Of Glioblastoma Multiforme In Newly Diagnosed Patients With Measurable Disease

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate (complete and partial) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 36
Study Start Date: February 2005
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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00082797

  Show 65 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Stuart A. Grossman, MD Sidney Kimmel Comprehensive Cancer Center
Investigator: Jana Portnow, MD Beckman Research Institute
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000360834, ECOG-E1F02
Study First Received: May 14, 2004
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00082797  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma

Study placed in the following topic categories:
Glioblastoma
Astrocytoma
Leucovorin
Central Nervous System Neoplasms
Folic Acid
Calcium, Dietary
Neuroectodermal Tumors
Glioblastoma multiforme
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Methotrexate
Glioma
Gliosarcoma
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Reproductive Control Agents
Neoplasms by Site
Vitamins
Therapeutic Uses
Abortifacient Agents
Micronutrients
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Vitamin B Complex
Neoplasms by Histologic Type
Growth Substances
Nervous System Diseases
Enzyme Inhibitors
Abortifacient Agents, Nonsteroidal
Folic Acid Antagonists
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Antirheumatic Agents
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on January 15, 2009