Status:
COMPLETED
Chemotherapy Toxicity Reduction Via Urea Cycle Support
Lead Sponsor:
Vanderbilt University
Conditions:
Cancer
Eligibility:
All Genders
13-65 years
Phase:
PHASE2
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 an...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00223730
Start Date
October 1 2001
End Date
December 1 2007
Last Update
November 2 2016
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232