RECRUITING

Antiangiogenic Therapy for Children with Recurrent Medulloblastoma, Ependymoma and ATRT

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

Patients with relapsed medulloblastoma, ependymoma and ATRT have a very poor prognosis whether treated with conventional chemotherapy, high-dose chemotherapy with stem cell rescue, irradiation or combinations of these modalities. Antiangiogenetic therapy has emerged as new treatment option in solid malignancies. The frequent, metronomic schedule targets both proliferating tumor cells and endothelial cells, and minimizes toxicity. In this study the investigators will evaluate the use of biweekly intravenous bevacizumab in combination with five oral drugs (thalidomide, celecoxib, fenofibrate, and alternating cycles of daily low-dose oral etoposide and cyclophosphamide), augmented with alternating courses of intrathecal etoposide and cytarabine. The aim of the study is to extend therapy options for children with recurrent or progressive medulloblastoma, ependymoma and ATRT, for whom no known curative therapy exists, by prolonging survival while maintaining good quality of life. The primary objective of the MEMMAT trial is to evaluate the activity of this multidrug antiangiogenic approach in these heavily pretreated children and young adults. Additionally, progression-free survival (PFS), overall survival (OS), as well as feasibility and toxicity will be examined.

Official Title

A Phase II Study of Metronomic and Targeted Anti-angiogenesis Therapy for Children with Recurrent/progressive Medulloblastoma, Ependymoma and ATRT

Quick Facts

Study Start:2014-04
Study Completion:2030-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01356290

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 19 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Relapsed or progressive medulloblastoma, ependymoma or ATRT (at least one site of untreated recurrent disease)
  2. * Histological confirmation of medulloblastoma, ependymoma or ATRT at diagnosis or relapse
  3. * Female or male, aged from 0 to \<20 years (at time of original diagnosis)
  4. * Participants must have normal organ and bone marrow function (ALT \<5x institutional upper limit of normal, creatinine \<1.5x institutional upper limit of normal for age, WBC \>1000/mm3, platelets \> 20,000/mm3. Patients with values less than WBC 2000/mm3 or platelets 50,000/mm3 will require initiation of treatment with etoposide and cyclophosphamide at a lower starting dose as defined within the protocol.
  5. * Karnofsky performance status ≥50. For infants and children less than 12 years of age, the Lansky play scale ≥50% will be used
  6. * Written informed consent of patients and / or parents
  1. * Active infection
  2. * VP-shunt dependency
  3. * Pregnancy or breast feeding
  4. * Conventional chemotherapy, antiangiogenic treatment or complete irradiation of all disease for current relapse (surgery may be performed before antiangiogenic treatment; patients with sites of disease not irradiated are still eligible for the protocol)
  5. * Known hypersensitivity to any of the drugs in the protocol
  6. * Active peptic ulcer
  7. * Any significant cardiovascular disease not controled by standard therapy e.g. systemic hypertension
  8. * Anticipation of the need for major elective surgery during the course of the study treatment
  9. * Any disease or condition that contraindicates the use of the study medication/treatment or places the patient at an unacceptable risk of experiencing treatment-related complications
  10. * Non-healing surgical wound
  11. * A bone fracture that has not satisfactorily healed

Contacts and Locations

Study Contact

Andreas Peyrl, MD
CONTACT
+43 1 40400
andreas.peyrl@meduniwien.ac.at
Irene Slavc, MD
CONTACT
+43 1 40400
irene.slavc@meduniwien.ac.at

Principal Investigator

Andreas Peyrl, MD
PRINCIPAL_INVESTIGATOR
Medical University of Vienna
Monika Chocholous, MD
STUDY_CHAIR
Medical University of Vienna

Study Locations (Sites)

Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611-2605
United States
Dana-Farber Cancer Institute and Boston Children's Hospital
Boston, Massachusetts, 02215
United States
Helen DeVos Children's Hospital
Grand Rapids, Michigan, 48503
United States
Dell Children's Medical Group SFC-HEM/ONC
Austin, Texas, 78723
United States

Collaborators and Investigators

Sponsor: Medical University of Vienna

  • Andreas Peyrl, MD, PRINCIPAL_INVESTIGATOR, Medical University of Vienna
  • Monika Chocholous, MD, STUDY_CHAIR, Medical University of Vienna

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 Date2014-04
Study Completion Date2030-04

Study Record Updates

Study Start Date2014-04
Study Completion Date2030-04

Terms related to this study

Keywords Provided by Researchers

  • Medulloblastoma
  • Ependymoma
  • ATRT
  • Relapse
  • Children
  • antiangiogenic
  • metronomic
  • intraventricular

Additional Relevant MeSH Terms

  • Medulloblastoma Recurrent
  • Ependymoma Recurrent
  • ATRT Recurrent