RERTEP: Surgery and Second-Course Radiation Therapy in Treating Younger Patients With Recurrent Ependymoma

A Phase II Trial of Surgery and Fractionated Re-irradiation for Recurrent Ependymoma

Categories:

Brain Tumor

Phase I/II

Diseases Treated:

Recurrent ependymoma

Eligibility Overview:

  • Progressive intracranial ependymoma after prior focal irradiation
  • At least 1 year old and younger than 21 years old
  • Adequate performance status (ECOG less than 3)
  • Does not require mechanical ventilation
  • Interval from start of initial radiation therapy to enrollment greater than 9 months
  1. Brief Summary

    Children with ependymoma who experience disease progression after surgery and radiation therapy have few options. Chemotherapy may prolong survival but is not curative, and surgeons are reluctant to approach recurrent disease without effective adjuvant therapy.

    St. Jude investigators have shown previously that a combination of additional surgery and radiation may be used successfully in certain patients with recurrent ependymoma. The goal of this study is to confirm the ability of a second course of surgery and radiation therapy to control recurrent ependymoma and identify which patients are most likely to benefit from this type of treatment. The study will also evaluate the effects of the tumor and treatment with the hope of reducing long-term side effects.

    Recurrence of ependymoma after initial treatment may be local, distant, or both. Local recurrence means that the tumor has regrown where it was originally located in the brain. Distant recurrence means that the tumor has regrown at a site in the brain or spine other than the original location. How additional surgery and radiation therapy are used in this study depends on whether the recurrence was local, distant or both.

    Primary Objective

    • To estimate the progression-free and overall survival distributions for children and young adults with recurrent ependymoma treated with a second course of irradiation while monitoring for excessive central nervous system necrosis

    Secondary Objective

    • To evaluate functional outcomes and host and tumor biology in patients with recurrent ependymoma treated with a second course of irradiation

    Eligibility criteria

    Inclusion criteria include:

    • Progressive intracranial ependymoma after prior focal irradiation
    • At least 1 year old and younger than 21 years old
    • Adequate performance status (ECOG less than 3)
    • Does not require mechanical ventilation
    • Interval from start of initial radiation therapy to enrollment greater than 9 months

    Exclusion criteria include:

    • Prior craniospinal irradiation
    • Pregnancy
    • Younger than 3 years old with metastatic ependymoma

    Study Design

    • Allocation: Non-Randomized
    • Endpoint Classification: Efficacy Study
    • Intervention Model: Parallel Assignment
    • Masking: Open Label
    • Primary Purpose: Treatment

    Study Sites

    St. Jude Children’s Research Hospital
    Memphis, Tennessee

  2. About this study

    Ependymoma is an aggressive brain tumor. Treatment usually involves surgery and radiation. Sometimes, the brain tumor comes back even after being treated. When this happens, surgery and chemotherapy alone are not likely to cure the cancer. In these cases, doctors may recommend a second round of radiation therapy. This is called re-irradiation. Most children and young people will need more surgery before re-irradiation to be sure that the tumor is ependymoma. This surgery may also help relieve symptoms and reduce the amount of tumor that radiation therapy is to treat.

    Purpose of this clinical trial

    The main purpose of this study is to see if surgery and a second round of radiation will help treat ependymoma that has come back after prior therapy. Researchers also want to study the good and bad effects of this treatment.

    Eligibility overview

    • Progressive intracranial ependymoma after prior focal irradiation
    • At least 1 year old and younger than 21 years old
    • Adequate performance status (ECOG less than 3)
    • Does not require mechanical ventilation
    • Interval from start of initial radiation therapy to enrollment greater than 9 months
  3. RERTEP  Quick View
    Sponsor St. Jude Children’s Research Hospital
    ClinicalTrials.gov identifier NCT02125786
    Trial start date

    April 2014

    Estimated enrollment

    99
    Study type Interventional
    Study phase Phase II
    Conditions Recurrent ependymoma
    Ages 1 to 21 years old
    Principal investigator Thomas E. Merchant, DO, PhD
    Study site St. Jude Children’s Research Hospital
    For a consultation or to discuss RERTEP St. Jude Physician/Patient Referral Office
    1-888-226-4343
    referralinfo@stjude.org

Contact

Thomas E. Merchant, DO, PhD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.