Texas Children's Cancer and Hematology Center  Vinblastine/Prednisone versus Single Therapy with Cytarabine for Langerhans Cell Histiocytosis (LCH) 

Description

Langerhans Cell Histiocytosis (LCH) is a type of blood cancer that can damage tissue or cause lesions to form in one or more places in the body. LCH is caused by overactive growth signals in specific blood cells that leads to abnormal differentiation. These cells develop into “Langerhans cells” in lesions where they can cause damage to normal tissue from accumulation abnormal cells and inflammation.

For most patients with LCH, standard-of-care vinblastine/prednisone are used as front-line therapy. Cytarabine therapy has been successfully used as therapy for some patients who develop recurrence. No alternate treatment strategy has been developed for frontline therapy in LCH. This study will determine which therapy is safest and most effective.

The purpose of this Phase 3 research study is to compare previously used vinblastine/prednisone to single therapy with cytarabine for LCH. We will also evaluate the utility of an imaging study called a positron emission tomography (PET) scan to more accurately assess areas of LCH involvement not otherwise seen in other imaging studies as well as response to therapy. We also want to identify if genetic and other biomarkers (special proteins in patient's blood and in patient's cancer) relate to the response of patients LCH to study treatment.

Eligibility Criteria

• Ages eligible for study: up to 21 years
• Patient must have biopsy-confirmed diagnosis of Langerhans cell histiocytosis.
• Patient must have a Karnofsky performance score ≥ 50% or Lansky performance score ≥ 50%.

Detailed inclusion and exclusion criteria as listed on clinicaltrials.gov.