Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI ECOG-E1F02 E1F02, NCT00082797

Objectives

Primary

1. Determine the response in patients with newly diagnosed glioblastoma multiforme treated with high-dose methotrexate and leucovorin calcium.

Secondary

1. Determine the acute toxicity of this regimen in these patients.
2. Determine the duration of survival of patients treated with this regimen.

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³

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

Expected Enrollment

A total of 19-36 patients will be accrued for this study.

Outcomes

Response rate (complete and partial)

Frequency of toxicity

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.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Stuart Grossman, MD, Protocol chair		Ph: 410-955-8837 Email: Grossman@jhmi.edu
Jana Portnow, MD, Protocol co-chair		Ph: 626-359-8111 ext. 62307; 800-826-4673

Registry Information
Official Title		A Phase II Study Of Systemic High-Dose Methotrexate For The Treatment Of Glioblastoma Multiforme In Newly Diagnosed Patients With Measurable Disease
Trial Start Date		2005-02-10
Registered in ClinicalTrials.gov		NCT00082797
Date Submitted to PDQ		2004-03-02
Information Last Verified		2006-10-19
NCI Grant/Contract Number		CA21115

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