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| Sponsors and Collaborators: |
NCI - Center for Cancer Research-Medical Oncology National Cancer Institute (NCI) Children's Oncology Group |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00018967 |
Purpose
RATIONALE: Chemoprotective drugs such as carboxypeptidase-G2 may protect normal cells from the toxic effects of chemotherapy.
PURPOSE: Clinical trial to study the effectiveness of carboxypeptidase-G2 in treating nervous system toxic effects in patients given an accidental overdose of intrathecal methotrexate.
| Condition | Intervention |
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Cancer-Related Problem/Condition Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: glucarpidase |
| MedlinePlus related topics: | Cancer |
| Drug Information available for: | Methotrexate |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Open Label |
| Official Title: | A Trial of Carboxypeptidase-G2 (CPDG2) For The Management of Patients With Intrathecal Methotrexate Overdose |
| Estimated Enrollment: | 10 |
| Study Start Date: | November 1993 |
| Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients undergo a lumbar puncture as soon as possible after methotrexate overdose to remove methotrexate and receive a single dose of carboxypeptidase-G2 intrathecally over 5 minutes.
Patients are followed for at least 1 month.
PROJECTED ACCRUAL: A maximum of 10 patients will be accrued for this study.
Eligibility
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations |
Show 103 Study Locations |
| NCI - Center for Cancer Research-Medical Oncology |
| National Cancer Institute (NCI) |
| Children's Oncology Group |
| Study Chair: | Brigitte C. Widemann, MD | NCI - Pediatric Oncology Branch |
| Study Chair: | Brigitte C. Widemann, MD | NCI - Pediatric Oncology Branch |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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Widemann BC, Balis FM, Shalabi A, Boron M, O'Brien M, Cole DE, Jayaprakash N, Ivy P, Castle V, Muraszko K, Moertel CL, Trueworthy R, Hermann RC, Moussa A, Hinton S, Reaman G, Poplack D, Adamson PC. Treatment of accidental intrathecal methotrexate overdose with intrathecal carboxypeptidase G2. J Natl Cancer Inst. 2004 Oct 20;96(20):1557-9.
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Widemann BC, Balis FM, Shalabi A, et al.: Carboxypeptidase-G2 (CPDG2) treatment of accidental intrathecal (IT) methotrexate (MTX) overdose. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-490, 2002.
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| Study ID Numbers: | CDR0000077521, NCI-92-C-0137N, CCG-0923, POG-9688, NCI-T92-0021N, COG-0923, COG-P9688 |
| First Received: | July 11, 2001 |
| Last Updated: | October 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00018967 |
| Health Authority: | United States: Food and Drug Administration |
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