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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00082797 |
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 | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors |
Drug: leucovorin calcium Drug: methotrexate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study Of Systemic High-Dose Methotrexate For The Treatment Of Glioblastoma Multiforme In Newly Diagnosed Patients With Measurable Disease |
Estimated Enrollment: | 36 |
Study Start Date: | February 2005 |
Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed glioblastoma multiforme (GBM)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
No prior administration of any of the following biologic agents for GBM:
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
At least 1 week since prior treatment with any of the following:
Study Chair: | Stuart A. Grossman, MD | Sidney Kimmel Comprehensive Cancer Center |
Investigator: | Jana Portnow, MD | Beckman Research Institute |
Study ID Numbers: | CDR0000360834, ECOG-E1F02 |
Study First Received: | May 14, 2004 |
Last Updated: | May 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00082797 History of Changes |
Health Authority: | United States: Federal Government |
adult glioblastoma adult giant cell glioblastoma adult gliosarcoma |
Antimetabolites Glioblastoma Immunologic Factors Folate Leucovorin Central Nervous System Neoplasms Vitamin B9 Neoplasms, Germ Cell and Embryonal Vitamins Methotrexate Neuroepithelioma Glioblastoma Multiforme Glioma Micronutrients |
Nervous System Neoplasms Vitamin B Complex Astrocytoma Trace Elements Folic Acid Antagonists Folinic Acid Immunosuppressive Agents Folic Acid Neuroectodermal Tumors Calcium, Dietary Gliosarcoma Antirheumatic Agents Neoplasms, Glandular and Epithelial |
Antimetabolites Glioblastoma Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Leucovorin Central Nervous System Neoplasms Reproductive Control Agents Neoplasms by Site Therapeutic Uses Neoplasms, Germ Cell and Embryonal Vitamins |
Abortifacient Agents Methotrexate Glioma Micronutrients Dermatologic Agents Nucleic Acid Synthesis Inhibitors Nervous System Neoplasms Neoplasms by Histologic Type Vitamin B Complex Astrocytoma Growth Substances Nervous System Diseases Enzyme Inhibitors Folic Acid Antagonists Abortifacient Agents, Nonsteroidal |