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Brain and Central Nervous System TumorsPhase 2NCT00082797

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

A Phase 2 study testing leucovorin calcium and methotrexate in people with Brain and Central Nervous System Tumors, run by Eastern Cooperative Oncology Group at 65 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Brain and Central Nervous System Tumors
What is being tested?
leucovorin calcium and methotrexate
How many people
36 participants
Where
65 sitesUnited States
Study dates
12 Jul 2005to May 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

65 sites in 1 country.

65 sites in 1 country

United States65 sites

  • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

    Allentown, Pennsylvania, 18105

  • Rush-Copley Cancer Care Center

    Aurora, Illinois, 60507

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-2410

  • St. Joseph Medical Center

    Bloomington, Illinois, 61701

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Graham Hospital

    Canton, Illinois, 61520

  • Memorial Hospital

    Carthage, Illinois, 62321

  • West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division

    Charleston, West Virginia, 25304

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611-3013

  • Hematology and Oncology Associates

    Chicago, Illinois, 60611

  • University of Illinois Cancer Center

    Chicago, Illinois, 60612-7243

  • Veterans Affairs Medical Center - Chicago Westside Hospital

    Chicago, Illinois, 60612

  • Mercy Hospital and Medical Center

    Chicago, Illinois, 60616

  • Swedish Covenant Hospital

    Chicago, Illinois, 60625

  • Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Eureka Community Hospital

    Eureka, Illinois, 61530

  • Mercy and Unity Cancer Center at Unity Hospital

    Fridley, Minnesota, 55432

  • Galesburg Clinic

    Galesburg, Illinois, 61401

  • Galesburg Cottage Hospital

    Galesburg, Illinois, 61401

  • Mason District Hospital

    Havana, Illinois, 62644

  • Hopedale Medical Complex

    Hopedale, Illinois, 61747

  • Midwest Center for Hematology/Oncology

    Joliet, Illinois, 60432

  • Joliet Oncology-Hematology Associates, Limited - West

    Joliet, Illinois, 60435

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • Kewanee Hospital

    Kewanee, Illinois, 61443

  • North Shore Oncology and Hematology Associates, Limited - Libertyville

    Libertyville, Illinois, 60048

  • McDonough District Hospital

    Macomb, Illinois, 61455

  • Minnesota Oncology Hematology, PA at Maplewood Cancer Center

    Maplewood, Minnesota, 55109

  • Marshfield Clinic - Marshfield Center

    Marshfield, Wisconsin, 54449

  • Saint Anthony Memorial Health Centers

    Michigan City, Indiana, 46360

  • Virginia Piper Cancer Institute at Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Mary Babb Randolph Cancer Center at West Virginia University Hospitals

    Morgantown, West Virginia, 26506

  • 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

  • Proctor Hospital

    Peoria, Illinois, 61614

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61615

  • Oncology Hematology Associates of Central Illinois, PC - Peoria

    Peoria, Illinois, 61615

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • OSF St. Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois Valley Community Hospital

    Peru, Illinois, 61354

  • Perry Memorial Hospital

    Princeton, Illinois, 61356

  • Hubert H. Humphrey Cancer Center at North Memorial Medical Center

    Robbinsdale, Minnesota, 55422-2900

  • Swedish-American Regional Cancer Center

    Rockford, Illinois, 61104-2315

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Health Services

    Saint Louis Park, Minnesota, 55416

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Medical X-Ray Center, PC

    Sioux Falls, South Dakota, 57105

  • Sioux Valley Hospital and University of South Dakota Medical Center

    Sioux Falls, South Dakota, 57117-5039

  • Hematology Oncology Associates - Skokie

    Skokie, Illinois, 60076

  • Hematology/Oncology of the North Shore at Gross Point Medical Center

    Skokie, Illinois, 60076

  • Midwest Cancer Research Group, Incorporated

    Skokie, Illinois, 60077

  • St. Margaret's Hospital

    Spring Valley, Illinois, 61362

  • Carle Cancer Center at Carle Foundation Hospital

    Urbana, Illinois, 61801

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Minnesota Oncology Hematology, PA - Woodbury

    Woodbury, Minnesota, 55125

Other trials in United States

About this study

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

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.

Read the 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.

Keywords
adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma
Medical subject headings
Central Nervous System Neoplasms, Glioblastoma, Gliosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate (complete and partial)

Secondary outcomes (1)

  1. Frequency of toxicity

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2004 (estimated)
  2. Study start12 Jul 2005
  3. Primary completionMay 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00082797
Sponsor's protocol ID
CDR0000360834
Other IDs
E1F02
Status last verified
Jun 2023
First submitted
14 May 2004
Last updated
15 Jun 2023
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing leucovorin calcium and methotrexate in people with Brain and Central Nervous System Tumors, run by Eastern Cooperative Oncology Group at 65 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate (complete and partial). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00082797.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.

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