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Chemotherapy Toxicity Reduction Via Urea Cycle Support

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ClinicalTrials.gov Identifier: NCT00223730
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Brian Christman, Vanderbilt University

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.


Condition or disease Intervention/treatment Phase
Cancer Drug: Citrulline Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Chemotherapy Toxicity Reduction Via Urea Cycle Support
Study Start Date : October 2001
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: citrulline
Patients randomized to receive oral citrulline at 3.8 gm/m2 in split BID dosing
Drug: Citrulline
Oral provision of amino acid citrulline to support impaired urea cycle function during escalated dose chemotherapy for stem cell transplant

Placebo Comparator: Placebo
Patients randomized to receive oral diluent for citrulline in BID dosing
Drug: Placebo




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Ages Eligible for Study:   13 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients will be excluded if pregnant (unlikely) or if informed consent cannot be obtained.
  • Because of the intrinsic toxicity of the treatment regimens, BMT is not usually offered to patients with severe underlying derangements in organ function. Nevertheless, other exclusions that will prevent entry of patients into the study include advanced renal or hepatic failure (serum creatinine > 6mg/dl, serum bilirubin >3.5 mg/dl), moribund patients, and patients whose primary physician is not committed to full support of the patient (i.e. "Do Not Resuscitate").
  • Other exclusions will include patients enrolled in another experimental (interventional) protocol aimed at reducing transplant related complications during BMT, patients testing positive for HIV, those who have had previous BMT, and patients actively bleeding at the time of initiation of induction therapy. We will not exclude patients undergoing newer regimens of cytotoxic chemotherapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00223730


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
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Principal Investigator: Brian W. Christman, MD Vanderbilt University Medical Center

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Responsible Party: Brian Christman, Professor of Medicine and Principal Investigator, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00223730     History of Changes
Other Study ID Numbers: 990675
NIH HL-55198 ( Other Identifier: NIH )
NIH 1P-30CA68485 ( Other Identifier: NIH )
NIH 1RO1-CA092313-01 ( Other Identifier: NIH )
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Keywords provided by Brian Christman, Vanderbilt University:
Peripheral Blood Stem Cell Transplant
Bone Marrow Transplant
Citrulline
Urea Cycle
Hepatic Injury
Allogeneic PBSCT
Matched-Unrelated PBSCT