Chemotherapy Toxicity Reduction Via Urea Cycle Support
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 13 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | October 2001 |
| End Date: | December 2007 |
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.
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.
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.
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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