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Diffuse Intrinsic Pontine Glioma (DIPG) Reirradiation (ReRT)

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ClinicalTrials.gov Identifier: NCT01469247
Recruitment Status : Active, not recruiting
First Posted : November 10, 2011
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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 or disease Intervention/treatment Phase
Brain Cancer Radiation: Radiation Therapy Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of Reirradiation of Recurrent or Progressive Brainstem Glioma
Actual Study Start Date : December 2011
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Optimal Dose Level Among Three Radiation Therapy (RT) Dose Levels [ Time Frame: 1 month after radiation therapy ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01469247


Locations
United States, Florida
Orlando Health
Orlando, Florida, United States, 32806
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Susan L. McGovern, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01469247     History of Changes
Other Study ID Numbers: 2011-0804
NCI-2011-03725 ( Registry Identifier: NCI CTRP )
R01CA187202 ( U.S. NIH Grant/Contract )
First Posted: November 10, 2011    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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