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A Phase II Study Of Systemic High-Dose Methotrexate For The Treatment Of Glioblastoma Multiforme In Newly Diagnosed Patients With Measurable Disease

Phase 2
18 Years
Not Enrolling
Brain and Central Nervous System Tumors

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Trial Information

A Phase II Study Of Systemic High-Dose Methotrexate For The Treatment Of Glioblastoma Multiforme In Newly Diagnosed Patients With Measurable Disease



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


- 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.

Inclusion Criteria


- 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



- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified


- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3


- SGOT ≤ 4.0 times upper limit of normal

- Bilirubin ≤ 2.0 mg/dL


- Creatinine ≤ 2.0 mg/dL

- Creatinine clearance ≥ 50 mL/min


- No uncontrolled hypertension

- No unstable angina

- No symptomatic congestive heart failure

- No uncontrolled cardiac arrhythmia

- No myocardial infarction within the past 6 months


- 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

- No other malignancy within the past 2 years except basal cell or squamous cell skin
cancer or carcinoma in situ of the cervix


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


- 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


- No prior cranial irradiation

- No prior radiotherapy for GBM


- Recovered from prior surgery


- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate (complete and partial)

Safety Issue:


Principal Investigator

Stuart A. Grossman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

February 2005

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult glioblastoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Glioblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms



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