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A Trial of Carboxypeptidase-G2 (CPDG2) for the Management of Patients with Intrathecal Methotrexate Overdose



A Trial of Carboxypeptidase-G2 (CPDG2) for the Management of Patients with Intrathecal Methotrexate Overdose

For Condition: Leukemia,Peripheral Nervous System Disease
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: Nonrandomized study. Intrathecal Methotrexate Rescue. Carboxypeptidase-G2, CPDG2, NSC-641273.
Details: Methotrexate is the most widely used intrathecal antineoplastic agent. Accidental IT overdose, usually the result of inadvertent IT injection of a higher dose intended for systemic administration, can produce severe and frequently lethal toxicity. Current therapeutic approaches are invasive and often ineffective. Carboxypeptidase-G2 (CPDG2), an enzyme that hydrolyzes the C-terminal glutamate residue from MTX, may potentially serve as a rescue agent for patients suffering from potentially lethal IT MTX overdoses. This trial will study the ability of a single IT injection of CPDG2 to rescue patients with IT MTX overdose.
Eligibility:
Study Type:  Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Any patient who receives an IT overdose of MTX greater than or equal to 100 mg will be eligible for the study. Written informed consent. EXCLUSION CRITERIA: Patients who have previously developed an anaphylactic reaction prior to CPDG(2) administration are ineligible. There will be no exclusions based on concurrent therapy.
Total Enrollment: 10

Location and Contact Information:

National Cancer Institute (NCI) *Recruiting*
Bethesda,  Maryland,  20892
United States
Recruiting Clinical  Support Center/NCI 1-888-624-1937


Additional Information:
Study ID Numbers:  920137;  92-C-0137
Study Start Date: March 28, 1992
Record last reviewed: February 1, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001299

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