High-Dose Methotrexate and Leucovorin in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
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| ClinicalTrials.gov Identifier: NCT00082797 |
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Recruitment Status :
Completed
First Posted : May 19, 2004
Last Update Posted : January 29, 2010
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Brain and Central Nervous System Tumors | Drug: leucovorin calcium Drug: methotrexate | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 36 participants |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 Start Date : | February 2005 |
| Actual Primary Completion Date : | May 2007 |
- Response rate (complete and partial)
- Frequency of toxicity
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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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
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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
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00082797
Show 65 study locations
| Study Chair: | Stuart A. Grossman, MD | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Study Chair: | Jana Portnow, MD | City of Hope Comprehensive Cancer Center |
| Responsible Party: | Group Chair, Eastern Cooperative Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00082797 |
| Other Study ID Numbers: |
CDR0000360834 E1F02 |
| First Posted: | May 19, 2004 Key Record Dates |
| Last Update Posted: | January 29, 2010 |
| Last Verified: | January 2010 |
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adult glioblastoma adult giant cell glioblastoma adult gliosarcoma |
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Glioblastoma Nervous System Neoplasms Central Nervous System Neoplasms Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases Leucovorin |
Methotrexate Calcium Levoleucovorin Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists |