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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

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Detailed Description:

Radiation Therapy Administration:

If you are found to be eligible to take part in this study, you will be assigned to a dose level of radiation therapy based on when you join this study. Three (3) dose levels of radiation therapy will be tested. Three (3) participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will be randomly assigned (as in the roll of dice) to one of the dose levels, and the assignment will also depend on how the previous participants have done. Participants will not be assigned to one of the higher 2 of the 3 dose levels unless the lower dose level is found to be tolerable. The first and second groups will receive 12 treatments and the third group will receive 14 treatments (Monday through Friday for about 2½ weeks). Your doctor will tell you how many treatments you will receive.

You may be given drugs to help prevent side effects. The study staff will tell you about these drugs, how they will be given, and the possible risks.

Study Visits:

About 2-4 days before you start radiation therapy, you will have a simulation. During the simulation session, a mask will be made of your face and head to keep you still. You will also have a computed tomography (CT) scan. This process allows the radiation planning to take place. Sedation by an anesthesiologist (anesthesia doctor) will be used if needed for young children to allow the radiotherapy to be delivered safely.

One (1) time a week for 3 weeks, and then 1 time a month (30 days +/- 10 days) for 2 months or unless the disease gets worse:

  • You will have a neurological exam.
  • Your performance status will be recorded.
  • You will fill out the quality-of-life questionnaire.
  • You will be asked about any side effects you may have had.

You will have a magnetic resonance imaging (MRI) scan of the brain within 1 month after joining the study.

Length of Treatment:

You may continue receiving radiation therapy for 12 or 14 treatments. You will no longer be able to receive radiation therapy if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Follow-up Visits:

One (1) month after you finish radiation therapy, at 6-8 weeks, then every 2-3 months after that from then on, you will have an MRI scan to check the status of the disease. The MRI scan will include advanced imaging to learn if the tumor has come back or if there is brain tissue damage from the radiation. With this type of imaging, a temporary infusion line with a bigger than standard size needle will be inserted to your vein if you do not already have a power port-a-cath in place. This may take between 20-30 minutes.

This is an investigational study. Radiation therapy in this study is delivered using FDA-approved and commercially available methods. It is investigational to find the best dose of radiation therapy to use for repeat radiation therapy.

Up to 30 participants will be enrolled in this study.


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

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, Learn About Clinical Studies.


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