Randomization of Cytarabine Monotherapy Versus Standard-of-Care Vinblastine/Prednisone for Frontline Treatment of Langerhans Cell Histiocytosis (TXCH LCH0115)

Who is this study for? Patients with Langerhans cell histiocytosis
Status: Recruiting
Location: See all (11) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Langerhans Cell Histiocytosis (LCH) is a type of cancer that can damage tissue or cause lesions to form in one or more places in the body. Langerhans cell histiocytosis (LCH) is a cancer that begins in LCH cells (a type of dendritic cell which fights infection). Sometimes there are mutations (changes) in LCH cells as they form. These include mutations of the BRAF gene. These changes may make the LCH cells grow and multiply quickly. This causes LCH cells to build up in certain parts of the body, where they can damage tissue or form lesions. For most patients with LCH, standard-of-care vinblastine/prednisone are used as front-line therapy while cytarabine therapy has been used as therapy for patients who develop recurrence. No alternate treatment strategy has been developed for frontline therapy in LCH. The purpose of this research study is to compare previously used vinblastine/prednisone to single therapy with cytarabine for LCH. We will 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
Participation Requirements
Sex: All
Maximum Age: 21
Healthy Volunteers: f
View:

• Patient must have biopsy-confirmed diagnosis of Langerhans cell histiocytosis.

• Patient must be between 0-21 years of age.

• Patient must have a Karnofsky performance score ≥ 50% or Lansky performance score ≥ 50%.

Locations
United States
California
Stanford Children's Hospital, Lucile Packard Children's Hospital
RECRUITING
Palo Alto
Rady Children's Hospital - San Diego
RECRUITING
San Diego
Minnesota
University of Minnesota/Masonic Cancer Center
WITHDRAWN
Minneapolis
Ohio
Nationwide Children's Hospital
RECRUITING
Columbus
Pennsylvania
Lehigh Valley Health Network- Cedar Crest
RECRUITING
Allentown
Texas
Dell Children's Medical Center
RECRUITING
Austin
Cook Children's Health Care System
RECRUITING
Fort Worth
Texas Children's Hospital
RECRUITING
Houston
Vannie Cook Children's Clinic
RECRUITING
Mcallen
Children's Hospital of San Antonio
RECRUITING
San Antonio
Virginia
Children's Hospital of The King's Daughters
RECRUITING
Norfolk
Contact Information
Primary
Olive Eckstein, MD
Eckstein@bcm.edu
832-822-4242
Backup
Carl E. Allen, MD, PhD
ceallen@txch.org
832-826-0860
Time Frame
Start Date: 2016-03-07
Estimated Completion Date: 2029-01
Participants
Target number of participants: 124
Treatments
Experimental: Cytarabine (experimental) arm
On this arm, patients will receive single therapy with cytarabine.
Active_comparator: Vinblastine/prednisone (standard) arm
On this arm, patients will receive standard-of-care therapy with vinblastine and prednisone.
Authors
Carle E. Allen
Sponsors
Leads: Baylor College of Medicine

This content was sourced from clinicaltrials.gov

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