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| Sponsor: | Histiocyte Society |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00276757 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Childhood Langerhans Cell Histiocytosis |
Drug: leucovorin calcium Drug: methotrexate Drug: prednisolone Drug: vinblastine sulfate |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | Treatment Protocol of the Third International Study For Langerhans Cell Histiocytosis |
Eligibility| Ages Eligible for Study: | up to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histopathologically confirmed diagnosis of Langerhans cell histiocytosis according to the criteria defined by the Histiocyte Society
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)
Multi-system low-risk disease
Single-system disease
Localized special site involvement, such as CNS-risk lesions with intracranial soft tissue extension or vertebral lesions with intraspinal soft tissue extension
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations
Show 33 Study Locations| Study Chair: | Kenneth L. McClain, MD, PhD | Texas Children's Cancer Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00276757 History of Changes |
| Other Study ID Numbers: | CDR0000454768, HISTSOC-LCH-III, CCLG-LCH-III, EU-20587, CCLG-LCH-2002-07, UMN-2006NT004 |
| Study First Received: | January 12, 2006 |
| Last Updated: | December 6, 2011 |
| Health Authority: | Unspecified |
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childhood Langerhans cell histiocytosis |
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Histiocytosis Histiocytosis, Langerhans-Cell Lymphatic Diseases Lung Diseases, Interstitial Lung Diseases Respiratory Tract Diseases Leucovorin Levoleucovorin Methylprednisolone Methylprednisolone Hemisuccinate Methotrexate Prednisolone Vinblastine Methylprednisolone acetate Prednisolone acetate |
Prednisolone phosphate Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Antidotes Protective Agents Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites |