Know Cancer

forgot password

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

Thank you

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



CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Rush-Copley Cancer Care Center Aurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - West Joliet, Illinois  60435
Carle Cancer Center at Carle Foundation Hospital Urbana, Illinois  61801
Saint Anthony Memorial Health Centers Michigan City, Indiana  46360
Bronson Methodist Hospital Kalamazoo, Michigan  49007
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
Borgess Medical Center Kalamazooaa, Michigan  49001
Fairview Ridges Hospital Burnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids, Minnesota  55433
Fairview Southdale Hospital Edina, Minnesota  55435
Mercy and Unity Cancer Center at Unity Hospital Fridley, Minnesota  55432
United Hospital St. Paul, Minnesota  55102
Ridgeview Medical Center Waconia, Minnesota  55387
Minnesota Oncology Hematology, PA - Woodbury Woodbury, Minnesota  55125
Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065
Medical X-Ray Center, PC Sioux Falls, South Dakota  57105
Avera Cancer Institute Sioux Falls, South Dakota  57105
Marshfield Clinic - Marshfield Center Marshfield, Wisconsin  54449
Methodist Medical Center of Illinois Peoria, Illinois  61636
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Sioux Valley Hospital and University of South Dakota Medical Center Sioux Falls, South Dakota  57117-5134
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division Charleston, West Virginia  25302
Mary Babb Randolph Cancer Center at West Virginia University Hospitals Morgantown, West Virginia  26506
University of Illinois Cancer Center Chicago, Illinois  60612-7243
Swedish-American Regional Cancer Center Rockford, Illinois  61104-2315
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Allentown, Pennsylvania  18105
Veterans Affairs Medical Center - Chicago Westside Hospital Chicago, Illinois  60612
Hematology Oncology Associates - Skokie Skokie, Illinois  60076
St. Joseph Medical Center Bloomington, Illinois  61701
Graham Hospital Canton, Illinois  61520
Memorial Hospital Carthage, Illinois  62321
Swedish Covenant Hospital Chicago, Illinois  60625
Mercy Hospital and Medical Center Chicago, Illinois  60616
Hematology and Oncology Associates Chicago, Illinois  60611
Eureka Community Hospital Eureka, Illinois  61530
Galesburg Cottage Hospital Galesburg, Illinois  61401
Galesburg Clinic Galesburg, Illinois  61401
Mason District Hospital Havana, Illinois  62644
Hopedale Medical Complex Hopedale, Illinois  61747
Midwest Center for Hematology/Oncology Joliet, Illinois  60432
Kewanee Hospital Kewanee, Illinois  61443
North Shore Oncology and Hematology Associates, Limited - Libertyville Libertyville, Illinois  60048
McDonough District Hospital Macomb, Illinois  61455
Northwest Medical Specialist, PC Niles, Illinois  60714
BroMenn Regional Medical Center Normal, Illinois  61761
Community Cancer Center Normal, Illinois  61761
Community Hospital of Ottawa Ottawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa, Illinois  61350
Cancer Treatment Center at Pekin Hospital Pekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria, Illinois  61615
OSF St. Francis Medical Center Peoria, Illinois  61637
Proctor Hospital Peoria, Illinois  61614
Illinois Valley Community Hospital Peru, Illinois  61354
Perry Memorial Hospital Princeton, Illinois  61356
Midwest Cancer Research Group, Incorporated Skokie, Illinois  60077
Hematology/Oncology of the North Shore at Gross Point Medical Center Skokie, Illinois  60076
St. Margaret's Hospital Spring Valley, Illinois  61362
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital Minneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Medical Center Robbinsdale, Minnesota  55422-2900
Park Nicollet Health Services St. Louis Park, Minnesota  55416
Minnesota Oncology Hematology, PA at Maplewood Cancer Center Maplewood, Minnesota  55109