NCT01469247

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2011

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 10, 2011

Completed
27 days until next milestone

Study Start

First participant enrolled

December 7, 2011

Completed
10.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2022

Completed
Last Updated

October 20, 2022

Status Verified

October 1, 2022

Enrollment Period

10.8 years

First QC Date

November 4, 2011

Last Update Submit

October 18, 2022

Conditions

Brain Cancer

Keywords

Brain cancerRecurrent or progressive brainstem gliomaDiffuse Intrinsic Pontine GliomaDIPGReirradiationReRTPhoton radiation therapyXRT

Outcome Measures

Primary Outcomes (1)

  • Optimal Dose Level Among Three Radiation Therapy (RT) Dose Levels

    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.

    1 month after radiation therapy

Study Arms (1)

Radiation Therapy

EXPERIMENTAL

Starting dose of 24 Gray (Gy) in 2 Gy fractions.

Radiation: Radiation Therapy

Interventions

Radiation TherapyRADIATION

Starting Dose 24 Gy in 2 Gy fractions.

Also known as: XRT, Reirradiation
Radiation Therapy

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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
  • Radiation therapy to brain for DIPG that was completed at least 10 months prior to planned reirradiation
  • 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.
  • Signed informed consent by patient and/or parents or legal guardian
  • Lansky/Karnofsky Performance Status score of 40-100
  • Central nervous system function defined as not severely somnolent or comatose (central cortical neurotoxicity scale \<Grade 3)
  • Life expectancy of \>/= 8 weeks

You may not qualify if:

  • Prior radiation of greater than 60 Gy to \>20% of brainstem.
  • Patients with Neurofibromatosis 1 because the biologic behavior of their tumors may be more benign
  • Asymptomatic patients because the primary goal of treatment is palliation of symptoms
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Orlando Health

Orlando, Florida, 32806, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Brain NeoplasmsRecurrenceDiffuse Intrinsic Pontine Glioma

Interventions

RadiotherapyRe-Irradiation

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueBrain Stem NeoplasmsInfratentorial Neoplasms

Intervention Hierarchy (Ancestors)

TherapeuticsRetreatment

Study Officials

  • Susan L. McGovern, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2011

First Posted

November 10, 2011

Study Start

December 7, 2011

Primary Completion

September 20, 2022

Study Completion

September 20, 2022

Last Updated

October 20, 2022

Record last verified: 2022-10

Locations

US(2)