Traumeel® S in Preventing and Treating Mucositis in Young Patients Undergoing Stem Cell Transplantation
Kidney Cancer, Leukemia, Lymphoma
About this trial
This is an interventional supportive care trial for Kidney Cancer focused on measuring oral complications, disseminated neuroblastoma, previously treated childhood rhabdomyosarcoma, recurrent Wilms tumor and other childhood kidney tumors, recurrent/refractory childhood Hodgkin lymphoma, recurrent childhood acute lymphoblastic leukemia, recurrent childhood acute myeloid leukemia, recurrent childhood large cell lymphoma, recurrent childhood lymphoblastic lymphoma, recurrent childhood rhabdomyosarcoma, recurrent childhood small noncleaved cell lymphoma, untreated childhood acute lymphoblastic leukemia, untreated childhood acute myeloid leukemia and other myeloid malignancies, childhood acute lymphoblastic leukemia in remission, childhood acute myeloid leukemia in remission, childhood chronic myelogenous leukemia, juvenile myelomonocytic leukemia, recurrent neuroblastoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Planned treatment with allogeneic or autologous hematopoietic stem cell transplantation Conditioning chemotherapy regimen for transplantation must be myeloablative Source of stem cells from any of the following: Bone marrow Placental cord Cytokine-mobilized peripheral blood Availability of 1 of the following donor types: HLA-matched sibling or parent Related donor mismatched for a single HLA locus (class I or II) Unrelated marrow or peripheral blood stem cell donor Unrelated umbilical cord blood HLA-matched or mismatched (class I) donor PATIENT CHARACTERISTICS: Age 3 to 25 Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Other No known allergy to Echinacea Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics Chemotherapy See Disease Characteristics Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other No concurrent oral vancomycin paste No concurrent oral glutamine supplementation No other mouth care or oral medications within 30 minutes after administration of study drugs No other concurrent treatment to prevent mouth sores
Sites / Locations
- University of Alabama at Birmingham Comprehensive Cancer Center
- Jonsson Comprehensive Cancer Center at UCLA
- Children's Hospital of Orange County
- Stanford Comprehensive Cancer Center at Stanford University Medical Center
- Children's National Medical Center
- University of Florida Shands Cancer Center
- Nemours Children's Clinic
- University of Miami Sylvester Comprehensive Cancer Center
- All Children's Hospital
- St. Joseph's Cancer Institute at St. Joseph's Hospital
- Winship Cancer Institute of Emory University
- Cancer Research Center of Hawaii
- Indiana University Cancer Center
- Holden Comprehensive Cancer Center at University of Iowa
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
- Children's Hospital of New Orleans
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Floating Hospital for Children at Tufts - New England Medical Center
- C.S. Mott Children's Hospital at University of Michigan
- Spectrum Health Hospital - Butterworth Campus
- Children's Hospitals and Clinics of Minneapolis
- University of Minnesota Medical Center & Children's Hospital - Fairview
- University of Mississippi Medical Center
- Siteman Cancer Center at Barnes-Jewish Hospital
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
- Schneider Children's Hospital
- Herbert Irving Comprehensive Cancer Center at Columbia University
- SUNY Upstate Medical University Hospital
- New York Medical College
- Rainbow Babies and Children's Hospital
- Oklahoma University Medical Center
- Children's Hospital of Pittsburgh
- Hollings Cancer Center at Medical University of South Carolina
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
- Cook Children's Medical Center - Fort Worth
- Methodist Children's Hospital of South Texas
- Children's Hospital of The King's Daughters
- Prince of Wales Private Hospital
- Westmead Institute for Cancer Research at Westmead Hospital
- Princess Margaret Hospital for Children
- Cancer Centre of Southeastern Ontario at Kingston General Hospital
- Montreal Children's Hospital at McGill University Health Center
- Hopital Sainte Justine
- Chaim Sheba Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Receive Traumeel S
Receive placebo