|
|
|
|
|
Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
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 |
MedlinePlus related topics: | Cancer |
ChemIDplus related topics: | Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Methotrexate Calcium gluconate |
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 |
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:
Show 65 Study Locations |
Eastern Cooperative Oncology Group |
National Cancer Institute (NCI) |
Study Chair: | Stuart A. Grossman, MD | Sidney Kimmel Comprehensive Cancer Center |
Investigator: | Jana Portnow, MD | Beckman Research Institute |
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
Study ID Numbers: | CDR0000360834, ECOG-E1F02 |
First Received: | May 14, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00082797 |
Health Authority: | United States: Federal Government |
|
|
|
|
|