Supersaturated Calcium Phosphate Rinse in Preventing Oral Mucositis in Young Patients Undergoing Autologous or Donor Stem Cell Transplant

• Status: Completed
• Trial end date: 2015-06-30
• Target enrollment: 0
• Participant gender: All

Summary

This randomized phase III trial is studying how well Caphosol rinse works in preventing mucositis in young patients undergoing autologous or donor stem cell transplant. Supersaturated calcium phosphate (Caphosol) rinse may be able to prevent mucositis, or mouth sores, in patients undergoing stem cell transplant.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Calcium; Calcium, Dietary

Criteria

Inclusion Criteria:

• Patients undergoing myeloablative autologous or allogeneic hematopoietic stem cell transplantation (HSCT) for any indication

• One or more of the following donor stem cell sources (autologous or allogeneic):

• Bone marrow

• Placental blood (umbilical cord blood)

• Cytokine-mobilized peripheral blood

• Patients eligible for allogeneic HSCT must have one of the following types of donor stem cells:

• Human leukocyte antigen (HLA)-matched sibling or parent

• Partially matched family donor (mismatched for a single HLA locus [Class I])

• Fully matched unrelated marrow or peripheral blood stem cell donor

• HLA-matched or partially mismatched (at least 4 of 6 match) cord blood (Class I or II)

• Patients expecting to receive any type of myeloablative HSCT conditioning regimen are eligible

• No non-myeloablative or reduced-intensity conditioning regimens

• Eligible patients must not have received palifermin within 30 days prior to enrollment

• Eligible patients must not have received prior treatment with Caphosol

Exclusion Criteria:

• Females of childbearing potential must have a negative pregnancy test; patients must agree to use an effective birth control method; lactating patients must agree not to nurse a child while on this trial