Chemotherapy Toxicity Reduction Via Urea Cycle Support

NCT00223730 | Completed Phase 2 DMC

• 4 other identifiers: 990675NIH HL-55198NIH 1P-30CA68485NIH 1RO1-CA092313-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Peripheral Blood Stem Cell Transplant; Bone Marrow Transplant; Citrulline; Urea Cycle; Hepatic Injury; Allogeneic PBSCT; Matched-Unrelated PBSCT

Study Arms (2)

citrulline

EXPERIMENTAL

Patients randomized to receive oral citrulline at 3.8 gm/m2 in split BID dosing

Drug: Citrulline

Placebo

PLACEBO COMPARATOR

Patients randomized to receive oral diluent for citrulline in BID dosing

Drug: Placebo

Interventions

Citrulline DRUG

Oral provision of amino acid citrulline to support impaired urea cycle function during escalated dose chemotherapy for stem cell transplant

citrulline

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 13 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• We propose to study 144 patients undergoing allogeneic bone marrow transplantation or peripheral blood stem cell transplant over a 4 year period.
• Patients of either sex and of any race or ethnic origin, older than age greater than or equal to13, and admitted to the Myelosuppression Unit (MSU) of Vanderbilt University Hospital or the VA Hospital to undergo bone marrow transplantation will be recruited for this study.

You may not qualify if:

• Patients will be excluded if pregnant (unlikely) or if informed consent cannot be obtained.

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Citrulline

Intervention Hierarchy (Ancestors)

Amino Acids, Diamino; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Brian W. Christman, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Principal Investigator

Study Record Dates

• First Submitted: September 19, 2005
• First Posted: September 22, 2005
• Study Start: October 1, 2001
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

US (1)