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| Sponsors and Collaborators: |
Roswell Park Cancer Institute National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003898 |
Purpose
RATIONALE: Glutamine may be able to decrease inflammation of the mouth and digestive system in children who are undergoing stem cell transplantation.
PURPOSE: Randomized double-blinded phase II trial to study the effectiveness of glutamine in reducing inflammation of the mouth and digestive system in children who are undergoing peripheral stem cell transplantation.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer-Related Problem/Condition Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: glutamine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized |
| Official Title: | The Use of Supplemental Oral Glutamine (GLN) to Decrease Morbidity in Patients Undergoing Stem Cell Transplantation: A Pediatric Blood and Marrow Transplant Consortium Study |
| Estimated Enrollment: | 120 |
| Study Start Date: | January 1999 |
OBJECTIVES: I. Determine the efficacy of supplemental oral glutamine in reducing the severity and duration of mucositis in children undergoing stem cell transplantation. II. Determine the safety of this regimen in these patients. III. Determine serum glutamine levels achieved during this regimen in these patients.
OUTLINE: This is a randomized, double blind, multicenter study. Patients are stratified according to inclusion of total body irradiation in the conditioning regimen (yes vs no). Patients receive either oral glutamine or oral placebo (glycine) twice a day beginning on the day of admission for the stem cell transplant and continuing for 28 days or until hospital discharge, whichever is first.
PROJECTED ACCRUAL: A total of 120 patients (60 per arm) will be accrued for this study within 2 years.
Eligibility| Ages Eligible for Study: | 1 Year to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Undergoing allogeneic or autologous stem cell transplant (including bone marrow, cord blood, or peripheral blood stem cells) Conditioning regimen must have at least 50% risk of grade III or IV mucositis No grade III or IV hepatic toxicity
PATIENT CHARACTERISTICS: Age: 1 to 21 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: See Disease Characteristics Renal: Not specified Other: No grade III or IV toxicity at admission for stem cell transplant No altered mental status
PRIOR CONCURRENT THERAPY: No concurrent vancomycin paste or nonabsorbable antibiotics
Contacts and Locations| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| United States, Texas | |
| Simmons Cancer Center - Dallas | |
| Dallas, Texas, United States, 75235-9154 | |
| Study Chair: | Barbara Jean Bambach, MD | Roswell Park Cancer Institute |
More Information
| Study ID Numbers: | CDR0000067069, RPCI-RP-9810, NCI-G99-1521 |
| Study First Received: | November 1, 1999 |
| Last Updated: | October 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003898 |
| Health Authority: | United States: Federal Government |
|
unspecified childhood solid tumor, protocol specific oral complications |
