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A Randomized Double Blind Placebo Controlled Clinical Trial to Assess the Efficacy of Traumeel® S (IND#66649) for the Prevention and Treatment of Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation


N/A
3 Years
25 Years
Not Enrolling
Both
Kidney Cancer, Leukemia, Lymphoma, Neuroblastoma, Oral Complications, Sarcoma

Thank you

Trial Information

A Randomized Double Blind Placebo Controlled Clinical Trial to Assess the Efficacy of Traumeel® S (IND#66649) for the Prevention and Treatment of Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation


OBJECTIVES:

- Compare the efficacy of Traumeel® S vs placebo in reducing the severity and duration of
chemotherapy-induced (with or without total body irradiation) mucositis in pediatric
patients undergoing hematopoietic stem cell transplantation.

- Determine the safety of this drug in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to treatment with total body irradiation during conditioning
chemotherapy (yes vs no), type of transplantation (autologous vs allogeneic), and
participating institution (COG vs foreign). Patients are randomized to 1 of 2 treatment
arms.

- Arm I: Patients receive oral Traumeel® S mouth rinse 5 times daily beginning on day -1
before transplantation.

- Arm II: Patients receive oral placebo mouth rinse 5 times daily beginning on day -1
before transplantation.

In both arms, treatment continues until day 20 post-transplantation OR until mucositis
resolves to Walsh score ≤ 1 for 2 consecutive days.

Patients are followed until day 100 post-transplantation.

PROJECTED ACCRUAL: A total of 180 patients (90 per treatment arm) will be accrued for this
study within 2 years.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Principal Investigator

Susan F. Sencer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Children's Hospitals and Clinics of Minnesota - Minneapolis

Authority:

United States: Federal Government

Study ID:

CDR0000356179

NCT ID:

NCT00080873

Start Date:

April 2004

Completion Date:

Related Keywords:

  • Kidney Cancer
  • Leukemia
  • Lymphoma
  • Neuroblastoma
  • Oral Complications
  • Sarcoma
  • 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
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Leukemia
  • Lymphoma
  • Neuroblastoma
  • Mucositis
  • Sarcoma

Name

Location

Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
New York Medical CollegeValhalla, New York  10595
University of Miami Sylvester Comprehensive Cancer CenterMiami, Florida  33136
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Children's Hospital of Orange CountyOrange, California  92668
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Nemours Children's ClinicJacksonville, Florida  32207
All Children's HospitalSt. Petersburg, Florida  33701
Children's Hospital of New OrleansNew Orleans, Louisiana  70118
Schneider Children's HospitalNew Hyde Park, New York  11042
Cook Children's Medical Center - Fort WorthFort Worth, Texas  76104
Children's Hospital of the King's DaughtersNorfolk, Virginia  23507
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032
Oklahoma University Medical CenterOklahoma City, Oklahoma  73104
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
St. Joseph's Cancer Institute at St. Joseph's HospitalTampa, Florida  33607
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
Floating Hospital for Children at Tufts - New England Medical CenterBoston, Massachusetts  02111
C.S. Mott Children's Hospital at University of MichiganAnn Arbor, Michigan  48109-0238
Children's Hospitals and Clinics of MinneapolisMinneapolis, Minnesota  55404
Albert Einstein Cancer Center at Albert Einstein College of MedicineBronx, New York  10461
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Rainbow Babies and Children's HospitalCleveland, Ohio  44106-5000
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
Methodist Children's Hospital of South TexasSan Antonio, Texas  78229-3993
Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781
Spectrum Health Hospital - Butterworth CampusGrand Rapids, Michigan  49503
University of Minnesota Medical Center & Children's Hospital - FairviewMinneapolis, Minnesota  55455
Stanford Comprehensive Cancer Center at Stanford University Medical CenterStanford, California  94305