Status:
COMPLETED
Combination Chemotherapy in Treating Young Patients With Langerhans Cell Histiocytosis
Lead Sponsor:
Histiocyte Society
Conditions:
Childhood Langerhans Cell Histiocytosis
Eligibility:
All Genders
Up to 17 years
Phase:
NA
Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of Langerhans cell histiocytosis, either by killing the cells or by stopping them from dividing. Giving more than one dr...
Detailed Description
OBJECTIVES: Primary * Compare the efficacy, in terms of response to initial therapy, of prednisolone, vinblastine, and mercaptopurine with vs without methotrexate and leucovorin calcium in young pat...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histopathologically confirmed diagnosis of Langerhans cell histiocytosis according to the criteria defined by the Histiocyte Society
- Demonstration of CD1a antigenic determinants on the surface of lesional cells (by immunocytology or immunohistology) or Birbeck granules in lesional cells by electron microscopy
- Considered at risk or low risk according to the following criteria:
- Multi-system at risk disease, defined as involvement of one or more risk organs (i.e., hematopoietic system, liver, spleen, or lungs)
- No single-system lung involvement
- Multi-system low-risk disease
- Multiple organs involved but without involvement of risk organs
- Single-system disease
- Multifocal bone disease (i.e., lesions in 2 or more different bones)
- Localized special site involvement, such as CNS-risk lesions with intracranial soft tissue extension or vertebral lesions with intraspinal soft tissue extension
- Vault lesions are not regarded as CNS-risk lesions
- PATIENT CHARACTERISTICS:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- PRIOR CONCURRENT THERAPY:
- No prior treatment for Langerhans cell histiocytosis
Exclusion
Key Trial Info
Start Date :
April 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2013
Estimated Enrollment :
376 Patients enrolled
Trial Details
Trial ID
NCT00276757
Start Date
April 1 2001
End Date
June 1 2013
Last Update
January 10 2014
Active Locations (33)
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1
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455
2
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
3
Vanderbilt Children's Hospital
Nashville, Tennessee, United States, 37232-9700
4
Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital
Houston, Texas, United States, 77030-2399