Trial Search Results

Fructooligosaccharides in Treating Patients With Blood Cancer Undergoing Donor Stem Cell Transplant

This pilot phase I trial studies the side effects and best dose of fructooligosaccharides in treating patients with blood cancer who are undergoing donor stem cell transplant. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Nutritional supplements such as fructooligosaccharides may reduce the incidence of graft-versus-host disease in patients with blood cancer undergoing donor stem cell transplant.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Other: Fructooligosaccharide
  • Other: Laboratory Biomarker Analysis

Phase:

Phase 1

Eligibility


Inclusion Criteria:

   - Patients included in the study will have a hematologic malignancy (any stage or grade)
   for which they are undergoing preparation for allogeneic HSCT; participants in the
   study will be restricted to those undergoing HSCT under reduced-intensity protocols
   9924 and 9907

   - No limitations exist for type or amount of prior therapy

   - No restrictions or requirements will be placed on race

   - No restrictions will be made based on life expectancy

   - Patients will not be evaluated based on Eastern Cooperative Oncology Group (ECOG) or
   Karnofsky performance status (KPS)

   - No restrictions will be made based on organ or marrow function

   - Patients will be included only if they have the ability to understand and the
   willingness to sign a written informed consent document

Exclusion Criteria:

   - Patients with a history of gastric bypass surgery or inflammatory bowel disease

   - Patients with a history of or current bowel obstruction

   - Patients actively enrolled on any other GVHD prevention trial

   - Patients with known fructose intolerance

   - Any physical or psychological condition that, in the opinion of the investigator,
   would pose unacceptable risk to the patient or raise concern that the patient would
   not comply with protocol procedures

   - Subjects may co-enroll on other investigational studies except for investigational
   studies whose primary aim is the prevention of GVHD

   - No additional restrictions exist regarding co-morbid disease or incurrent illness

   - Patients will be excluded from the trial if they have had a history of allergies or
   intolerance to fructooligosaccharides or the components of FOS including fructose and
   glucose

   - No exclusion is necessary based on the use of other concomitant medications;
   specifically there is no prohibition of concomitant antibiotic, antiviral or
   antifungal therapy; subjects may co-enroll on other investigational studies except for
   investigational studies whose primary aim is the prevention of GVHD

   - Pregnant or nursing patients will not be included in the study

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting