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The Use of Supplemental Oral Glutamine (GLN) to Decrease Morbidity in Patients Undergoing Stem Cell Transplantation: A Pediatric Blood and Marrow Transplant Consortium Study


Phase 2
1 Year
21 Years
Not Enrolling
Both
Oral Complications, Unspecified Childhood Solid Tumor, Protocol Specific

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Trial Information

The Use of Supplemental Oral Glutamine (GLN) to Decrease Morbidity in Patients Undergoing Stem Cell Transplantation: A Pediatric Blood and Marrow Transplant Consortium Study


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Principal Investigator

Barbara Jean Bambach, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000067069

NCT ID:

NCT00003898

Start Date:

January 1999

Completion Date:

January 2004

Related Keywords:

  • Oral Complications
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • unspecified childhood solid tumor, protocol specific
  • oral complications

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Simmons Cancer Center - DallasDallas, Texas  75235-9154