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

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
leucovorin calcium
methotrexate
Sponsored by
Eastern Cooperative Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rush-Copley Cancer Care Center
  • St. Joseph Medical Center
  • Graham Hospital
  • Memorial Hospital
  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
  • Hematology and Oncology Associates
  • University of Illinois Cancer Center
  • Veterans Affairs Medical Center - Chicago Westside Hospital
  • Mercy Hospital and Medical Center
  • Swedish Covenant Hospital
  • Eureka Community Hospital
  • Galesburg Clinic
  • Galesburg Cottage Hospital
  • Mason District Hospital
  • Hopedale Medical Complex
  • Midwest Center for Hematology/Oncology
  • Joliet Oncology-Hematology Associates, Limited - West
  • Kewanee Hospital
  • North Shore Oncology and Hematology Associates, Limited - Libertyville
  • McDonough District Hospital
  • Northwest Medical Specialist, PC
  • BroMenn Regional Medical Center
  • Community Cancer Center
  • Community Hospital of Ottawa
  • Oncology Hematology Associates of Central Illinois, PC - Ottawa
  • Cancer Treatment Center at Pekin Hospital
  • Proctor Hospital
  • CCOP - Illinois Oncology Research Association
  • Oncology Hematology Associates of Central Illinois, PC - Peoria
  • Methodist Medical Center of Illinois
  • OSF St. Francis Medical Center
  • Illinois Valley Community Hospital
  • Perry Memorial Hospital
  • Swedish-American Regional Cancer Center
  • Hematology Oncology Associates - Skokie
  • Hematology/Oncology of the North Shore at Gross Point Medical Center
  • Midwest Cancer Research Group, Incorporated
  • St. Margaret's Hospital
  • Carle Cancer Center at Carle Foundation Hospital
  • CCOP - Carle Cancer Center
  • Saint Anthony Memorial Health Centers
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Borgess Medical Center
  • West Michigan Cancer Center
  • Bronson Methodist Hospital
  • Fairview Ridges Hospital
  • Mercy and Unity Cancer Center at Mercy Hospital
  • Fairview Southdale Hospital
  • Mercy and Unity Cancer Center at Unity Hospital
  • Minnesota Oncology Hematology, PA at Maplewood Cancer Center
  • Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
  • Hubert H. Humphrey Cancer Center at North Memorial Medical Center
  • CCOP - Metro-Minnesota
  • Park Nicollet Health Services
  • United Hospital
  • Ridgeview Medical Center
  • Minnesota Oncology Hematology, PA - Woodbury
  • Case Comprehensive Cancer Center
  • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
  • Avera Cancer Institute
  • Medical X-Ray Center, PC
  • Sioux Valley Hospital and University of South Dakota Medical Center
  • West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
  • Mary Babb Randolph Cancer Center at West Virginia University Hospitals
  • Marshfield Clinic - Marshfield Center

Outcomes

Primary Outcome Measures

Response rate (complete and partial)

Secondary Outcome Measures

Frequency of toxicity

Full Information

First Posted
May 14, 2004
Last Updated
June 14, 2023
Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00082797
Brief Title
High-Dose Methotrexate and Leucovorin in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Official Title
A Phase II Study Of Systemic High-Dose Methotrexate For The Treatment Of Glioblastoma Multiforme In Newly Diagnosed Patients With Measurable Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 12, 2005 (Actual)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
leucovorin calcium
Intervention Type
Drug
Intervention Name(s)
methotrexate
Primary Outcome Measure Information:
Title
Response rate (complete and partial)
Secondary Outcome Measure Information:
Title
Frequency of toxicity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart A. Grossman, MD
Organizational Affiliation
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jana Portnow, MD
Organizational Affiliation
City of Hope Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Rush-Copley Cancer Care Center
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60507
Country
United States
Facility Name
St. Joseph Medical Center
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
Graham Hospital
City
Canton
State/Province
Illinois
ZIP/Postal Code
61520
Country
United States
Facility Name
Memorial Hospital
City
Carthage
State/Province
Illinois
ZIP/Postal Code
62321
Country
United States
Facility Name
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3013
Country
United States
Facility Name
Hematology and Oncology Associates
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Illinois Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-7243
Country
United States
Facility Name
Veterans Affairs Medical Center - Chicago Westside Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Mercy Hospital and Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
Swedish Covenant Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60625
Country
United States
Facility Name
Eureka Community Hospital
City
Eureka
State/Province
Illinois
ZIP/Postal Code
61530
Country
United States
Facility Name
Galesburg Clinic
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Galesburg Cottage Hospital
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Mason District Hospital
City
Havana
State/Province
Illinois
ZIP/Postal Code
62644
Country
United States
Facility Name
Hopedale Medical Complex
City
Hopedale
State/Province
Illinois
ZIP/Postal Code
61747
Country
United States
Facility Name
Midwest Center for Hematology/Oncology
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60432
Country
United States
Facility Name
Joliet Oncology-Hematology Associates, Limited - West
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Kewanee Hospital
City
Kewanee
State/Province
Illinois
ZIP/Postal Code
61443
Country
United States
Facility Name
North Shore Oncology and Hematology Associates, Limited - Libertyville
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Facility Name
McDonough District Hospital
City
Macomb
State/Province
Illinois
ZIP/Postal Code
61455
Country
United States
Facility Name
Northwest Medical Specialist, PC
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
BroMenn Regional Medical Center
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Community Cancer Center
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Community Hospital of Ottawa
City
Ottawa
State/Province
Illinois
ZIP/Postal Code
61350
Country
United States
Facility Name
Oncology Hematology Associates of Central Illinois, PC - Ottawa
City
Ottawa
State/Province
Illinois
ZIP/Postal Code
61350
Country
United States
Facility Name
Cancer Treatment Center at Pekin Hospital
City
Pekin
State/Province
Illinois
ZIP/Postal Code
61554
Country
United States
Facility Name
Proctor Hospital
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
CCOP - Illinois Oncology Research Association
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Oncology Hematology Associates of Central Illinois, PC - Peoria
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Methodist Medical Center of Illinois
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61636
Country
United States
Facility Name
OSF St. Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Illinois Valley Community Hospital
City
Peru
State/Province
Illinois
ZIP/Postal Code
61354
Country
United States
Facility Name
Perry Memorial Hospital
City
Princeton
State/Province
Illinois
ZIP/Postal Code
61356
Country
United States
Facility Name
Swedish-American Regional Cancer Center
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61104-2315
Country
United States
Facility Name
Hematology Oncology Associates - Skokie
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Hematology/Oncology of the North Shore at Gross Point Medical Center
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Midwest Cancer Research Group, Incorporated
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
St. Margaret's Hospital
City
Spring Valley
State/Province
Illinois
ZIP/Postal Code
61362
Country
United States
Facility Name
Carle Cancer Center at Carle Foundation Hospital
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
CCOP - Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Saint Anthony Memorial Health Centers
City
Michigan City
State/Province
Indiana
ZIP/Postal Code
46360
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States
Facility Name
Borgess Medical Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49001
Country
United States
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-3731
Country
United States
Facility Name
Bronson Methodist Hospital
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Fairview Ridges Hospital
City
Burnsville
State/Province
Minnesota
ZIP/Postal Code
55337
Country
United States
Facility Name
Mercy and Unity Cancer Center at Mercy Hospital
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Facility Name
Fairview Southdale Hospital
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Mercy and Unity Cancer Center at Unity Hospital
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Minnesota Oncology Hematology, PA at Maplewood Cancer Center
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Facility Name
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
City
Robbinsdale
State/Province
Minnesota
ZIP/Postal Code
55422-2900
Country
United States
Facility Name
CCOP - Metro-Minnesota
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Park Nicollet Health Services
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
United Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Ridgeview Medical Center
City
Waconia
State/Province
Minnesota
ZIP/Postal Code
55387
Country
United States
Facility Name
Minnesota Oncology Hematology, PA - Woodbury
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18105
Country
United States
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Medical X-Ray Center, PC
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Sioux Valley Hospital and University of South Dakota Medical Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117-5039
Country
United States
Facility Name
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Facility Name
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Marshfield Clinic - Marshfield Center
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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