Status:
COMPLETED
Coproporphyrine Isomers and Methotrexate Elimination
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Central Nervous System Neoplasms
Lymphoma, Large B-Cell, Diffuse
Eligibility:
All Genders
18+ years
Brief Summary
High dose methotrexate (MTX) is responsible of severe toxicity in patients in whom elimination from plasma is delayed. Factors responsible for MTX accumulation are partly known but some patients still...
Detailed Description
MTX is a substrate of MRP2, a renal tubular transporter encoded by the ABCC2 gene. It has been shown that single nucleotide polymorphisms (SNPs) on the ABCC2 gene are associated with impairment of MTX...
Eligibility Criteria
Inclusion
- Inclusion criteria :
- Patients receiving HDMTX (≥1g/m2) for a primitive cerebral lymphoma, a large cell lymphoma, a lymphoblastic lymphoma, a Burkitt's lymphoma or an acute lymphoblastic leukaemia,
- over 18 years old,
- Signed informed consent.
- Affiliated to a medical assurance.
- Able to respect the protocol.
- Effective contraception for women.
- Exclusion criteria :
- renal failure,
- liver failure,
- hepatic cytolysis,
- chronic respiratory deficiency,
- pregnancy,
- breast-feeding,
- Concomitant medication: phenytoin, probenecid, trimethoprim, phenylbutazone, salicylates, non steroid anti-inflammatory, yellow fever vaccine.
- Patient included in another study in the four weeks preceding his inclusion.
Exclusion
Key Trial Info
Start Date :
October 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT00822432
Start Date
October 1 2007
End Date
August 1 2011
Last Update
July 31 2012
Active Locations (2)
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1
Pitié-Salpêtrière Hospital
Paris, France, 75013
2
University Hospital Centre of Tours
Tours, France, 37000