Overview

Combination Chemotherapy in Treating Young Patients With Langerhans Cell Histiocytosis

Status:
Completed
Trial end date:
2013-06-01
Target enrollment:
0
Participant gender:
All
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 drug (combination chemotherapy) may be an effective treatment for Langerhans cell histiocytosis. PURPOSE: This randomized clinical trial is studying combination chemotherapy to see how well it works in treating young patients with Langerhans cell histiocytosis.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Histiocyte Society
Treatments:
Calcium
Leucovorin
Levoleucovorin
Methotrexate
Prednisolone
Vinblastine
Criteria
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