Diffuse Intrinsic Pontine Glioma (DIPG) Reirradiation (ReRT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01469247
First received: November 4, 2011
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

The goal of this clinical research study is to find a safe dose of radiation that can be given to patients with brainstem glioma who have already received radiation therapy.

You will receive photon radiation therapy. This type of radiation is similar to the radiation you have already had. Conformal radiotherapy or intensity modulated radiotherapy (IMRT) will be used to try to treat the tumor while affecting as little of the surrounding normal tissue as possible.


Condition Intervention Phase
Brain Cancer
Radiation: Radiation Therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Study of Reirradiation of Recurrent or Progressive Brainstem Glioma

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Optimal Dose Level Among Three Radiation Therapy (RT) Dose Levels [ Time Frame: 1 month after radiation therapy ] [ Designated as safety issue: Yes ]
    Optimal dose level among three RT dose levels, defined in terms of the biologically equivalent dose (BED). The BED is given by the formula BED = (Total Dose)*(1 + d/3), denoting d = dose/fraction, with the constant 3 corresponding to brain tissue.


Estimated Enrollment: 30
Study Start Date: December 2011
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radiation Therapy
Starting dose of 24 Gray (Gy) in 2 Gy fractions.
Radiation: Radiation Therapy
Starting Dose 24 Gy in 2 Gy fractions.
Other Names:
  • XRT
  • Reirradiation

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of DIPG by MRI imaging defined as tumor that has a pontine epicenter and is diffuse (tumor that involves the majority (>50%) of the brainstem) on T2 or FLAIR imaging rather than focal. Histologic confirmation is not required
  2. Radiation therapy to brain for DIPG that was completed at least 10 months prior to planned reirradiation
  3. Clinical progression of symptoms with any radiographic progression on MRI within 21 days prior to registration (any progression in size or enhancement on MRI along with worsening symptoms, will be defined as progression prior to enrollment). Radiographic progression is defined as any increase in tumor size (in axial or sagittal images) or progressive contrast enhancement and abnormal T2/FLAIR signal by MRI.
  4. Signed informed consent by patient and/or parents or legal guardian
  5. Lansky/Karnofsky Performance Status score of 40-100
  6. Central nervous system function defined as not severely somnolent or comatose (central cortical neurotoxicity scale <Grade 3)
  7. Life expectancy of >/= 8 weeks

Exclusion Criteria:

  1. Prior radiation of greater than 60 Gy to >20% of brainstem.
  2. Patients with Neurofibromatosis 1 because the biologic behavior of their tumors may be more benign
  3. Asymptomatic patients because the primary goal of treatment is palliation of symptoms
  4. Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01469247

Contacts
Contact: Anita Mahajan, MD 713-563-2300

Locations
United States, Florida
Orlando Health Recruiting
Orlando, Florida, United States, 32806
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Anita Mahajan, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01469247     History of Changes
Other Study ID Numbers: 2011-0804, NCI-2011-03725
Study First Received: November 4, 2011
Last Updated: April 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Brain cancer
Recurrent or progressive brainstem glioma
Diffuse Intrinsic Pontine Glioma
DIPG
Reirradiation
ReRT
Photon radiation therapy
XRT

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Glioma
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 20, 2014