Re-Irradiation of Progressive or Recurrent DIPG

Study Purpose

This is a single-arm, non-randomized study of re-irradiation of diffuse intrinsic pontine glioma (DIPG)

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	N/A and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

All of these criteria must be met for a patient to be eligible for this study: 1. Each site may accept a patient on study of any age that they have permission to treat and follow on study per their institutional policy. 2. The patient has no evidence of metastases on cranial or spinal MR imaging. 3. The patient has received RT in the past, given to a total cumulative dose of <60 Gy; prior radiation using opposed lateral fields, conformal 3-D fields, IMRT or using protons is acceptable. 4. At least 180 days have elapsed from the last day of primary RT for DIPG. 5. The patient has recovered from all acute and subacute toxicities of prior RT and of chemotherapy, if chemotherapy was utilized in the past. 6. The patient has been off all anti-tumour therapy for at least 14 days. 7. The patient has a Lansky score of 40% or higher. 8. The patient has a life expectancy anticipated to be at least 8 weeks with treatment using re-irradiation, with or without dexamethasone. 9. The patient has no uncontrolled medical condition (e.g., seizures, diabetes, infection) that would interfere with the delivery of rRT. 10. The patient agrees to not enroll on any other clinical trial of an anti-tumour intervention. 11. The patient agrees to report and have recorded the use of all medications taken during ReRAD therapy, from the time of diagnosis of progression or recurrence, then through and after completion of, ReRAD therapy; this includes the use of complementary, alternative and dietary therapies. 12. The patient is treated at a site where the study is approved by the local ethics board. 13. Males and females of child-bearing potential must agree to use effective birth control measures during rRT. 14. Consent, and, if applicable, assent, has been obtained according to institutional standards.

Exclusion Criteria:

If the patient fulfills any of these criteria, then he or she will not be eligible for the study: 1. Females who are pregnant, due to risks from rRT on the developing fetus. 2. Any patient with a condition that prohibits the planned delivery of rRT as prescribed in this study. 3. Patients who are receiving any other clinical trial of an anti-tumour intervention

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03126266
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Calgary
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Lucie Lafay-Cousin, MD
Principal Investigator Affiliation	University of Calgary
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Australia, Canada, New Zealand
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Recurrent or Progressive Diffuse Intrinsic Pontine Glioma

Additional Details

Study therapy will consist of radiation therapy (RT) given over 17 treatment days (for 30.6 Gy in fractions of 1.8 Gy) or 20 treatment days (for 36 Gy in 1.8 Gy fractions), depending on the time from completion of the first course of RT. Treatment days will generally be weekdays, not including statutory holidays.

Arms & Interventions

Arms

Experimental: Patients receiving re-irradiation

Patients will receive 30.6 Gy or 36 Gy of a second course of radiation therapy for progressive or recurrent DIPG

Interventions

Radiation: - re-irradiation

if DIPG has progressed or recurred at 180 days or later from completion of primary radiation therapy, a second course of radiation therapy will be given

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

The Children's Hospital at Westmead, Westmead, New South Wales, Australia

Status

Recruiting

Address

The Children's Hospital at Westmead

Westmead, New South Wales,

Site Contact

Dinisha Govender, MD

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