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| Sponsored by: |
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 |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| 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
| 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: | June 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00276757 History of Changes |
| Health Authority: | Unspecified |
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childhood Langerhans cell histiocytosis |
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Anti-Inflammatory Agents Antimetabolites Immunologic Factors Methylprednisolone Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Folate Leucovorin Vinblastine Prednisolone acetate Hormones Vitamin B9 Histiocytosis X Respiratory Tract Diseases Histiocytosis |
Vitamins Methotrexate Micronutrients Methylprednisolone Hemisuccinate Langerhans Cell Histiocytosis Letterer-Siwe Disease Lung Diseases, Interstitial Vitamin B Complex Antineoplastic Agents, Hormonal Methylprednisolone acetate Trace Elements Antimitotic Agents Folinic Acid Histiocytosis, Langerhans-Cell Folic Acid Antagonists |
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Anti-Inflammatory Agents Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Leucovorin Vinblastine Reproductive Control Agents Hormones Respiratory Tract Diseases Histiocytosis Vitamins |
Therapeutic Uses Abortifacient Agents Methotrexate Micronutrients Dermatologic Agents Nucleic Acid Synthesis Inhibitors Lung Diseases, Interstitial Vitamin B Complex Reticuloendotheliosis Antineoplastic Agents, Hormonal Growth Substances Mitosis Modulators Enzyme Inhibitors Antimitotic Agents Folic Acid Antagonists |