RECRUITING

Vinblastine/Prednisone Versus Single Therapy With Cytarabine for Langerhans Cell Histiocytosis (LCH)

Conditions

Langerhans Cell Histiocytosis vinblastine prednisone cytarabine Langerhans Cell Histiocytosis (LCH)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2016-03-07

Study Completion:2029-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02670707

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
1. Patient must have biopsy-confirmed diagnosis of Langerhans cell histiocytosis. 2. Patient must be between 0-21 years of age. 3. Patient must have a Karnofsky performance score ≥ 50% or Lansky performance score ≥ 50%.	1. Patient may not have received any prior systemic cytotoxic or other chemotherapies for LCH or any other malignant disorder prior to the initiation of protocol therapy on TXCH LCH0115 with the exception of: 2. Patient may not have disease limited to a single skin or bone site, with the following exceptions: * Central Nervous System (CNS) risk lesions/special site disease: patients with single bone sites that are CNS-risk (sphenoid, mastoid, orbital, zygomatic, ethmoid, maxillary, or temporal bones, the cranial fossa, pituitary gland or neurodegenerative disease) or are "special sites" (odontoid peg, vertebral lesion with intraspinal soft tissue extension) require systemic therapy as standard of care and thus are eligible for the study. * Functionally critical lesions: A single lesion not described above which may cause "functionally critical anatomic abnormality" wherein attempts at local therapy (such as surgical curettage or radiation) would cause unacceptable morbidity. These patients may be enrolled with written approval of the Coordinating Center PI or Vice-Chair and documentation of the rationale justifying systemic therapy. * Asynchronous multisite LCH presentation: A patient may also have any single site of disease involvement at the time of enrollment if they previously had at least one other site of LCH disease in the past (which may have been treated with local therapy/surgery as described), as long as no systemic therapy was previously given per protocol guidelines. 3. Patient may not have severe renal disease (creatinine greater than 3 times normal for age OR creatinine clearance \< 50 ml/m2/1.73m\^2). 4. Patient may not have severe hepatic disease (direct bilirubin greater than 3 mg/dl OR aspartate aminotransferase (AST) greater than 500 IU/L), unless hepatic injury is due to LCH. 5. Female patients may not be pregnant or breastfeeding. 6. Patients of reproductive potential not willing to use an adequate method of birth control for the duration of the study. 7. Patients who are HIV positive may not be enrolled.

Inclusion Criteria

Exclusion Criteria

1. Patient must have biopsy-confirmed diagnosis of Langerhans cell histiocytosis.
2. Patient must be between 0-21 years of age.
3. Patient must have a Karnofsky performance score ≥ 50% or Lansky performance score ≥ 50%.

1. Patient may not have received any prior systemic cytotoxic or other chemotherapies for LCH or any other malignant disorder prior to the initiation of protocol therapy on TXCH LCH0115 with the exception of:
2. Patient may not have disease limited to a single skin or bone site, with the following exceptions:
* Central Nervous System (CNS) risk lesions/special site disease: patients with single bone sites that are CNS-risk (sphenoid, mastoid, orbital, zygomatic, ethmoid, maxillary, or temporal bones, the cranial fossa, pituitary gland or neurodegenerative disease) or are "special sites" (odontoid peg, vertebral lesion with intraspinal soft tissue extension) require systemic therapy as standard of care and thus are eligible for the study.
* Functionally critical lesions: A single lesion not described above which may cause "functionally critical anatomic abnormality" wherein attempts at local therapy (such as surgical curettage or radiation) would cause unacceptable morbidity. These patients may be enrolled with written approval of the Coordinating Center PI or Vice-Chair and documentation of the rationale justifying systemic therapy.
* Asynchronous multisite LCH presentation: A patient may also have any single site of disease involvement at the time of enrollment if they previously had at least one other site of LCH disease in the past (which may have been treated with local therapy/surgery as described), as long as no systemic therapy was previously given per protocol guidelines.
3. Patient may not have severe renal disease (creatinine greater than 3 times normal for age OR creatinine clearance \< 50 ml/m2/1.73m\^2).
4. Patient may not have severe hepatic disease (direct bilirubin greater than 3 mg/dl OR aspartate aminotransferase (AST) greater than 500 IU/L), unless hepatic injury is due to LCH.
5. Female patients may not be pregnant or breastfeeding.
6. Patients of reproductive potential not willing to use an adequate method of birth control for the duration of the study.
7. Patients who are HIV positive may not be enrolled.

Contacts and Locations

Study Contact

Olive Eckstein, MD

CONTACT

832-822-4242

Eckstein@bcm.edu

Carl E. Allen, MD, PhD

CONTACT

832-826-0860

ceallen@txch.org

Principal Investigator

Olive Eckstein, MD

STUDY_CHAIR

Baylor College of Medicine

Study Locations (Sites)

Stanford Children's Hospital, Lucile Packard Children's Hospital

Palo Alto, California, 94304

United States

Rady Children's Hospital - San Diego

San Diego, California, 92123

United States

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, 55455

United States

Nationwide Children's Hospital

Columbus, Ohio, 43205

United States

Lehigh Valley Health Network- Cedar Crest

Allentown, Pennsylvania, 18103

United States

Dell Children's Medical Center

Austin, Texas, 78723

United States

Cook Children's Health Care System

Fort Worth, Texas, 76104

United States

Texas Children's Hospital

Houston, Texas, 77030

United States

Vannie Cook Children's Clinic

McAllen, Texas, 78503

United States

Children's Hospital of San Antonio

San Antonio, Texas, 78207

United States

Children's Hospital of The King's Daughters

Norfolk, Virginia, 23507

United States

Collaborators and Investigators

Sponsor: Baylor College of Medicine

Olive Eckstein, MD, STUDY_CHAIR, Baylor College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-03-07

Study Completion Date2029-01

Study Record Updates

Study Start Date2016-03-07

Study Completion Date2029-01

Terms related to this study

Keywords Provided by Researchers

vinblastine
prednisone
cytarabine
Langerhans Cell Histiocytosis (LCH)

Additional Relevant MeSH Terms

Langerhans Cell Histiocytosis