Sponsor study identifier
Secondary identifiers
interventional
4
1 country
2
Study Start
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2011
Actual (reported)Study Completion
July 2011
Actual (reported)RATIONALE: Drugs used in chemotherapy, such as methotrexate and leucovorin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Glucarpidase may help return the level of methotrexate in the blood to a safe range. Giving high-dose methotrexate together with glucarpidase and leucovorin may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of methotrexate when given together with glucarpidase and leucovorin in treating patients with newly diagnosed primary central nervous system lymphoma.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
August 1, 2008
Actual (reported)August 4, 2008
Actual (reported)July 2011
Actual (reported)July 2011
Actual (reported)Immediate toxicity (incidence of reactions to glucarpidase) as determined by the NCI CTC
Incidence and severity of renal dysfunction as determined by the NCI CTC
Incidence and severity of mucositis as determined by the NCI CTC and WHO mucositis grading scale
Incidence and severity of CNS toxicity and neurocognitive changes taken from patients' medical records and measured using the Mini-Mental State questionnaire and MRI data
Hematological toxicity (i.e., number of courses of therapy associated with neutrophils < 0.5 x 10e9/L or platelets < 50 x 10e9/L as measured by routine blood counts)
Incidence of infection (i.e., number of days with fever ≥ 38 C° measured by clinical examination and days of intravenous antibiotics taken from patients' medical records)
Number of inpatient days taken from patients' medical records
Leeds General Infirmary
Leeds, England, LS1 3EX, United Kingdom
Torbay Hospital
Torquay, England, TQ2 7AA, United Kingdom
Roderick Johnson, MD
Leeds General Infirmary
4 participants (actual enrollment reported by the registry).
First Submitted
August 1, 2008
First Posted
August 4, 2008
Study Start
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
Disease response and remission rates measured by serial MRI scanning (and eye examination and lumbar puncture if necessary)
Disease outcome, time to progression, and overall survival at 2 years from start of therapy measured by clinical examination and serial MRI scanning
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Primary Completion
July 2011
Actual (reported)Study Completion
July 2011
Actual (reported)Last Updated
January 27, 2014
Record last verified: 2014-01
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Source: ClinicalTrials.gov.
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