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| Sponsor: | Children's Cancer and Leukaemia Group |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00513981 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as high-dose methotrexate work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as leucovorin calcium, may protect normal cells from the side effects of chemotherapy.
PURPOSE: This phase I trial is studying the side effects, best way to give, and best dose of high-dose methotrexate in treating patients with solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors Sarcoma Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: leucovorin calcium Drug: methotrexate Other: mass spectrometry Other: pharmacological study |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Study to Determine the Maximum Tolerated Time of Infusion for High-Dose Methotrexate, Administered as a Continuous Intravenous Infusion at a Dose of 6g/m² Per 24 Hours of Infusion Time |
| Estimated Enrollment: | 36 |
| Study Start Date: | March 2007 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients receive a continuous infusion of high-dose methotrexate IV over 24, 30, 36, or 42 hours depending on time of study entry. Beginning at hour 42 or 48, patients receive leucovorin calcium IV every 6 hours for 3 days or until plasma methotrexate concentration is < 0.2 µM. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline and periodically during study and analyzed for pharmacodynamic effects on plasma homocysteine and methionine by gas chromatography/mass spectrometry techniques.
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven malignancy, including but not limited to, any of the following:
Patients with MRI findings in keeping with a diffuse intrinsic pontine glioma will be eligible without histological confirmation of tumor type
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
Exclusion criteria:
Contacts and Locations| Ireland | |
| Our Lady's Hospital for Sick Children Crumlin | |
| Dublin, Ireland, 12 | |
| United Kingdom, England | |
| Addenbrooke's Hospital | |
| Cambridge, England, United Kingdom, CB2 2QQ | |
| Birmingham Children's Hospital | |
| Birmingham, England, United Kingdom, B4 6NH | |
| Bristol Royal Hospital for Children | |
| Bristol, England, United Kingdom, BS2 8BJ | |
| Children's Hospital - Sheffield | |
| Sheffield, England, United Kingdom, S10 2TH | |
| Queen's Medical Centre | |
| Nottingham, England, United Kingdom, NG7 2UH | |
| Leeds Cancer Centre at St. James's University Hospital | |
| Leeds, England, United Kingdom, LS9 7TF | |
| Leicester Royal Infirmary | |
| Leicester, England, United Kingdom, LE1 5WW | |
| Oxford Radcliffe Hospital | |
| Oxford, England, United Kingdom, 0X3 9DU | |
| Great Ormond Street Hospital for Children | |
| London, England, United Kingdom, WC1N 3JH | |
| Royal Liverpool Children's Hospital, Alder Hey | |
| Liverpool, England, United Kingdom, L12 2AP | |
| Royal Manchester Children's Hospital | |
| Manchester, England, United Kingdom, M27 4HA | |
| Royal Marsden - Surrey | |
| Sutton, England, United Kingdom, SM2 5PT | |
| Sir James Spence Institute of Child Health | |
| Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP | |
| Southampton General Hospital | |
| Southampton, England, United Kingdom, SO16 6YD | |
| University College Hospital | |
| London, England, United Kingdom, NW1 2PCE | |
| United Kingdom, Northern Ireland | |
| Royal Belfast Hospital for Sick Children | |
| Belfast, Northern Ireland, United Kingdom, BT12 6BE | |
| United Kingdom, Scotland | |
| Royal Aberdeen Children's Hospital | |
| Aberdeen, Scotland, United Kingdom, AB25 2ZG | |
| Royal Hospital for Sick Children | |
| Glasgow, Scotland, United Kingdom, G3 8SJ | |
| Royal Hospital for Sick Children | |
| Edinburgh, Scotland, United Kingdom, EH9 1LF | |
| United Kingdom, Wales | |
| Childrens Hospital for Wales | |
| Cardiff, Wales, United Kingdom, CF14 4XW | |
| Principal Investigator: | Eddy J. Estlin | Royal Manchester Children's Hospital |
More Information
| Study ID Numbers: | CDR0000560133, CCLG-NAG-2005-13, EU-20744, EUDRACT-2005-001757-13 |
| Study First Received: | August 8, 2007 |
| Last Updated: | August 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00513981 History of Changes |
| Health Authority: | United States: Federal Government |
|
unspecified childhood solid tumor, protocol specific recurrent osteosarcoma recurrent childhood soft tissue sarcoma |
recurrent childhood ependymoma untreated childhood brain stem glioma recurrent childhood brain stem glioma |
|
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Leucovorin Central Nervous System Neoplasms Reproductive Control Agents Neoplasms, Connective and Soft Tissue Neoplasms by Site Vitamins Therapeutic Uses Abortifacient Agents Methotrexate |
Micronutrients Dermatologic Agents Nucleic Acid Synthesis Inhibitors Nervous System Neoplasms Vitamin B Complex Neoplasms by Histologic Type Growth Substances Nervous System Diseases Enzyme Inhibitors Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Pharmacologic Actions Neoplasms Sarcoma |