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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
N/A
Not Enrolling
Both
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


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.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate (complete and partial)

Safety Issue:

No

Principal Investigator

Stuart A. Grossman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000360834

NCT ID:

NCT00082797

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

Name

Location

CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Minnesota Oncology Hematology, PA - WoodburyWoodbury, Minnesota  55125
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Medical X-Ray Center, PCSioux Falls, South Dakota  57105
Avera Cancer InstituteSioux Falls, South Dakota  57105
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Sioux Valley Hospital and University of South Dakota Medical CenterSioux Falls, South Dakota  57117-5134
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston DivisionCharleston, West Virginia  25302
Mary Babb Randolph Cancer Center at West Virginia University HospitalsMorgantown, West Virginia  26506
University of Illinois Cancer CenterChicago, Illinois  60612-7243
Swedish-American Regional Cancer CenterRockford, Illinois  61104-2315
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Morgan Cancer Center at Lehigh Valley Hospital - Cedar CrestAllentown, Pennsylvania  18105
Veterans Affairs Medical Center - Chicago Westside HospitalChicago, Illinois  60612
Hematology Oncology Associates - SkokieSkokie, Illinois  60076
St. Joseph Medical CenterBloomington, Illinois  61701
Graham HospitalCanton, Illinois  61520
Memorial HospitalCarthage, Illinois  62321
Swedish Covenant HospitalChicago, Illinois  60625
Mercy Hospital and Medical CenterChicago, Illinois  60616
Hematology and Oncology AssociatesChicago, Illinois  60611
Eureka Community HospitalEureka, Illinois  61530
Galesburg Cottage HospitalGalesburg, Illinois  61401
Galesburg ClinicGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
Hopedale Medical ComplexHopedale, Illinois  61747
Midwest Center for Hematology/OncologyJoliet, Illinois  60432
Kewanee HospitalKewanee, Illinois  61443
North Shore Oncology and Hematology Associates, Limited - LibertyvilleLibertyville, Illinois  60048
McDonough District HospitalMacomb, Illinois  61455
Northwest Medical Specialist, PCNiles, Illinois  60714
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - PeoriaPeoria, Illinois  61615
OSF St. Francis Medical CenterPeoria, Illinois  61637
Proctor HospitalPeoria, Illinois  61614
Illinois Valley Community HospitalPeru, Illinois  61354
Perry Memorial HospitalPrinceton, Illinois  61356
Midwest Cancer Research Group, IncorporatedSkokie, Illinois  60077
Hematology/Oncology of the North Shore at Gross Point Medical CenterSkokie, Illinois  60076
St. Margaret's HospitalSpring Valley, Illinois  61362
Virginia Piper Cancer Institute at Abbott-Northwestern HospitalMinneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Medical CenterRobbinsdale, Minnesota  55422-2900
Park Nicollet Health ServicesSt. Louis Park, Minnesota  55416
Minnesota Oncology Hematology, PA at Maplewood Cancer CenterMaplewood, Minnesota  55109