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MEMMAT: Antiangiogenic Therapy for Children With Recurrent Medulloblastoma, Ependymoma and ATRT

Summary

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. This study will evaluate the use of biweekly IV administration of bevacizumab in combination with five drugs taken orally (thalidomide, celecoxib, fenofibrate, and alternating cycles of daily low-dose oral etoposide and cyclophosphamide), augmented with alternating courses of intrathecal etoposide and cytarabine. The goal of this study is to provide additional 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 previously treated children and young adults. Progression-free survival (PFS), overall survival (OS), as well as feasibility and toxicity will be examined.

Trial Information

Screening–Doctors will review the patient’s medical history to make sure that this study treatment is appropriate

Treatment – Treatment can take up to 12 months if the cancer does not continue to grow, and there are no unacceptable side effects.

Approach

Treatment:

a. Intravenous (IV medications)

  • Bevacizumab (Avastin) – given biweekly

b. Oral

  • Thalidomide – given daily

  • Celecoxib – given daily

  • Fenofibric acid – given daily

  • Etoposide

  • Cylclophosphamide

c. Intrathecal

  • Etoposide phosphate - given twice weekly, 2 out of every 4 weeks alternating with cytarabine

  • Cytarabine – given twice weekly, 2 out of every 4 weeks alternating with etoposide phosphate

Additional Information

NCT01356290

View on ClinicalTrials.gov

Eligibility

Inclusion Criteria

  • Relapsed or progressive medulloblastoma, ependymoma or ATRT (at least one site of untreated recurrent disease)

  • Histological confirmation of medulloblastoma, ependymoma or ATRT at diagnosis or relapse

  • Female or male, aged from 0 to <20 years (at the time of original diagnosis)

  • Labs confirming adequate organ and bone marrow function

  • Karnofsky performance status ≥50. For infants and children 12 years of age, the Lansky play scale ≥50% will be used

  • Written informed consent of patients and/or parents


Exclusion Criteria

  • Active infection

  • VP-shunt dependency

  • Pregnancy or breast feeding

  • 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).

  • Patients that have received a allogeneic hematopoietic stem cell transplant are not eligible

  • Known hypersensitivity to any of the drugs in the protocol

  • Active peptic ulcer

  • Any significant cardiovascular disease not controlled by standard therapy (e.g. systemic hypertension)

  • Anticipated need for major elective surgery during the course of study treatment

  • Any disease/condition that contraindicates the use of study medication/treatment or places the patient at an unacceptable risk of experiencing treatment-related complications

  • Non-healing surgical wound

  • A bone fracture that has not satisfactorily healed

Contact Information

Study Contact: Andreas Peryl, MD

University of Vienna

Email: andreas.peyrl@meduniwien.ac.at

Phone: +43 1 40400 ext 32320


Study Contact: Irene Slavc, MD

Email: irene.slavc@meduniwien.ac.at

Phone: +43 1 40400 ext 32320

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