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Sponsored by: |
Cancer Research UK |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00727831 |
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.
Condition | Intervention | Phase |
---|---|---|
Cancer-Related Problem/Condition Lymphoma |
Drug: glucarpidase Drug: leucovorin calcium Drug: methotrexate Procedure: laboratory biomarker analysis Procedure: quality-of-life assessment Procedure: radiation therapy |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase I Trial of Escalating High Dose Methotrexate Supported by Glucarpidase to Treat Patients With Primary Central Nervous Lymphoma (PCNSL) |
Estimated Enrollment: | 20 |
Study Start Date: | July 2008 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, dose-escalation study of high-dose methotrexate (HD-MTX).
Patients receive HD-MTX IV over 4 hours on day 1. Beginning 22 hours after the start of HD-MTX, patients receive glucarpidase IV over 15 minutes on day 2 followed by leucovorin calcium orally or IV on days 2-7. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Within 2-4 weeks after completion of study treatment, patients achieving maximum response are stratified according to age (< 60 years vs ≥ 60 years) and may undergo whole brain radiotherapy (WBRT) once daily, 5 days a week, for 3 to 5 weeks.
Patients undergo blood sample collection periodically to assess glucarpidase antibodies and MTX levels.
Patients are assessed for mucositis incidence and severity periodically, and complete quality of life assessments using the EORTC QLQ-30 questionnaire and the Mini-Mental State questionnaire at baseline, during, and after completion of study.
After completion of study treatment, patients are followed at 6 weeks after WBRT, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed newly diagnosed primary CNS lymphoma (PCNSL)
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
PRIOR CONCURRENT THERAPY:
United Kingdom, England | |
Leeds General Infirmary | Recruiting |
Leeds, England, United Kingdom, LS1 3EX | |
Contact: Roderick Johnson, MD 44-113-392-3766 | |
Torbay Hospital | Recruiting |
Torquay, England, United Kingdom, TQ2 7AA | |
Contact: Deborah Turner 44-180-365-5244 deborah.turner2@nhs.net |
Principal Investigator: | Roderick Johnson, MD | Leeds General Infirmary |
Study ID Numbers: | CDR0000599206, CRUK-BRD/07/004, 2007-002570-58, EU-20861 |
Study First Received: | August 1, 2008 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00727831 |
Health Authority: | Unspecified |
neurotoxicity chemotherapeutic agent toxicity mucositis primary central nervous system lymphoma contiguous stage II adult diffuse large cell lymphoma |
noncontiguous stage II adult diffuse large cell lymphoma stage I adult diffuse large cell lymphoma stage III adult diffuse large cell lymphoma stage IV adult diffuse large cell lymphoma |
Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Mucositis Neurotoxicity Syndromes Neurotoxicity syndromes Leucovorin Central nervous system lymphoma, primary |
Folic Acid Lymphoma, large-cell Lymphatic Diseases Calcium, Dietary Methotrexate Lymphoproliferative Disorders Lymphoma |
Antimetabolites Antimetabolites, Antineoplastic Neoplasms by Histologic Type Vitamin B Complex Immunologic Factors Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Reproductive Control Agents |
Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Pharmacologic Actions Neoplasms Vitamins Therapeutic Uses Abortifacient Agents Micronutrients Antirheumatic Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors |