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Brief Title: Chemotherapy Toxicity Reduction Via Urea Cycle Support
Official Title: Chemotherapy Toxicity Reduction Via Urea Cycle Support
Study ID: NCT00223730
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:
Minimum Age: 13 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Name: Brian W. Christman, MD
Affiliation: Vanderbilt University Medical Center
Role: PRINCIPAL_INVESTIGATOR