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Spots Global Cancer Trial Database for Chemotherapy Toxicity Reduction Via Urea Cycle Support

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Trial Identification

Brief Title: Chemotherapy Toxicity Reduction Via Urea Cycle Support

Official Title: Chemotherapy Toxicity Reduction Via Urea Cycle Support

Study ID: NCT00223730

Conditions

Cancer

Interventions

Citrulline
Placebo

Study Description

Brief Summary: Patients undergoing bone marrow transplantation (BMT) and peripheral blood stem cell transplants (PBSCT) frequently develop organ dysfunctions, much of which may be initiated by damage to the liver and to cells lining blood vessels. We, the researchers at Vanderbilt University, propose to perform a randomized, prospective, double-blind, placebo-controlled study of 144 patients undergoing allogeneic marrow transplantation. The treatment is aimed at supporting hepatic urea cycle function in patients receiving escalated dose chemotherapy/BMT. By so doing we hope to prevent development of hepatic venoocclusive disease (HVOD) and acute lung injury (ALI), two morbid complications of BMT. Patients will be randomized to receive oral citrulline, a urea cycle amino acid intermediate, or placebo beginning before conditioning therapy and continuing until 21 days after BMT. All patients will be followed for 100 days after study enrollment with intensive data collection.

Detailed Description:

Eligibility

Minimum Age: 13 Years

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Vanderbilt University Medical Center, Nashville, Tennessee, United States

Contact Details

Name: Brian W. Christman, MD

Affiliation: Vanderbilt University Medical Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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