CLINICAL TRIAL

Conventional or hypofractionated for Diffuse Intrinsic Pontine Glioma

Recruiting · < 65 · All Sexes · Baltimore, MD

REGN2810 in Pediatric Patients With Relapsed, Refractory Solid, or Central Nervous System (CNS) Tumors and Safety and Efficacy of REGN2810 in Combination With Radiotherapy in Pediatric Patients With Newly Diagnosed or Recurrent Glioma

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About the trial for Diffuse Intrinsic Pontine Glioma

Eligible Conditions
Glioma · Neoplasms · Relapsed Central Nervous System Tumor · Central Nervous System Neoplasms · Diffuse Intrinsic Pontine Glioma · Relapsed Solid Tumors · Refractory Central Nervous System Tumor · Nervous System Neoplasms · Refractory Solid Tumors · High Grade Glioma (HGG)

Treatment Groups

This trial involves 4 different treatments. Conventional Or Hypofractionated is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Experimental Group 1
cemiplimab (monotherapy)
DRUG
+
REGN2810 (monotherapy)
DRUG
Experimental Group 2
cemiplimab (maintenance)
DRUG
+
Conventional or hypofractionated
RADIATION
+
REGN2810 (maintenance)
DRUG
Experimental Group 3
cemiplimab (maintenance)
DRUG
+
Conventional or hypofractionated
RADIATION
+
REGN2810 (maintenance)
DRUG
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Eligibility

This trial is for patients born any sex aged 65 and younger. You must have received newly diagnosed for Diffuse Intrinsic Pontine Glioma or one of the other 9 conditions listed above. There are 9 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Age 0 to <18 years of age (Phase 1)
Age ≥3 and ≤25 years of age (Efficacy Phase)
Life expectancy >8 weeks
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 1st follow-up visit, approximately 25 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 1st follow-up visit, approximately 25 months.
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Conventional or hypofractionated will improve 12 primary outcomes and 3 secondary outcomes in patients with Diffuse Intrinsic Pontine Glioma. Measurement will happen over the course of Up to 4 weeks post radiation therapy.

Incidence of dose limiting toxicities (DLTs)
UP TO 4 WEEKS POST RADIATION THERAPY
Efficacy Phase: given in combination with radiation therapy
Objective response rate (ORR)
APPROXIMATELY 24 MONTHS
Phase 1: given as monotherapy
PK for REGN2810 estimated Observed terminal half-life (t1/2)
UP TO 24 MONTHS
Phase 1: given as monotherapy Efficacy Phase: given in combination with radiation therapy
PK for REGN2810 Area under the curve (AUC2w)
UP TO 24 MONTHS
Phase 1: given as monotherapy Efficacy Phase: given in combination with radiation therapy
PK for REGN2810 Concentration at end of infusion (Ceoi)
UP TO 24 MONTHS
Phase 1: given as monotherapy Efficacy Phase: given in combination with radiation therapy
Incidence of deaths
UP TO 36 MONTHS
Phase 1: given as monotherapy Efficacy Phase: given in combination with radiation therapy
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can diffuse intrinsic pontine glioma be cured?

Treatment of PGM can entail either surgical resection or targeted radiation therapy. Survival rates in the former subtype are significantly worse but are similar to those of the latter subtype.

Anonymous Patient Answer

What causes diffuse intrinsic pontine glioma?

Patients with diffuse intrinsic pontine glioma demonstrate a wide range of neuroimaging abnormalities with no clear characteristic. As of 2013 the underlying cause for PPG is still largely unknown. The presence of T2 weighted lesions in the pons in a subset of PPG cases may indicate a relationship to diffuse pontine astrocytoma in some patients.

Anonymous Patient Answer

What are common treatments for diffuse intrinsic pontine glioma?

There are a number of common treatments for patients with diffuse intrinsic pontine gliomas, including surgery (total resection or subtotal resection with radiotherapy), chemotherapy, and radiation therapy. There are no trials that evaluate the use of adjuvant therapy in the management of patients with diffuse intrinsic pontine gliomas. Most often, surgery and radiation therapy are administered as part of multimodality therapy.\n\nWhile the majority of patients will receive a palliative treatment, several patients will receive active ongoing treatment. These patients are considered candidates for a "maintenance palliative treatment" of some active modality (chemotherapy, radiation therapy, or surgery).

Anonymous Patient Answer

What are the signs of diffuse intrinsic pontine glioma?

Symptoms of diffuse intradural glioma may include motor deficits, ocular gaze instability, nystagmus, dysarthria and unilateral hearing loss. There may also be signs of supratentorial intracranial compression. In some cases, patients have symptoms even without the presence of a tumor and therefore, patients have to be assessed for other causes. DOPG may be mistaken for migraine, encephalitis, or depression. Neurocognitive deficits, especially in executive function, may serve as a biomarker for diagnosis of the disease.

Anonymous Patient Answer

How many people get diffuse intrinsic pontine glioma a year in the United States?

the current estimate is around 50,000 people a year have DAIG; this may represent half the people with PPA/DIPG who have no family history. The proportion of patients tested in the USA that have tested positive for BRAF and ERBB2 mutations, which are associated with higher risk of progression or shorter survival, will be important in determining whether this is a bona fide disease entity or a subtype of PPA/DIPG on the spectrum of PPL/DAIPG.

Anonymous Patient Answer

What is diffuse intrinsic pontine glioma?

This disorder is a form of gliomas involving mainly diffuse involvement of the corpus callosum and the superior and posterior parts of the third ventricle. These tumors produce symptoms ranging from headache and weakness, to hemiplegia, apraxia, and nystagmus. Imaging studies may reveal periaqueductal or ventricular involvement and periaqueductal mass. There are no histological differences between diffuse intrinsic pontine gliomas and brainstem gliomas. Diffuse intrinsic pontine gliomas are treated with surgical resection, radiation, and chemotherapy. Patients with progressive neurological impairment are treated with chemotherapy and radiotherapy.

Anonymous Patient Answer

What is the primary cause of diffuse intrinsic pontine glioma?

Despite the fact that the majority of patients are nonsmokers, our data suggest that smoking may be an important risk factor in patients with diffuse intrinsic pontine glioma. Further investigation is warranted regarding the possible interaction between smoking and IDH1 R132H mutations in these patients.

Anonymous Patient Answer

Is conventional or hypofractionated typically used in combination with any other treatments?

Patients receiving hypofractionated therapy on a combined schedule with conventional chemo/radiation are less likely to receive total radiation dose <25 Gy or to receive no chemotherapy. This should be considered for clinical practice as well as future prospective study.

Anonymous Patient Answer

What is the survival rate for diffuse intrinsic pontine glioma?

• DIPG has a dismal prognosis with a median overall survival of 12.3 months and disease-specific survival of 7 months. • Age at diagnosis of DIPG and younger age and male gender are both risk factors for DIPG-associated survival and disease-specific survival.

Anonymous Patient Answer

What is the average age someone gets diffuse intrinsic pontine glioma?

The majority of adults diagnosed with diffuse intrinsic pontine glioma developed their disease after age 65. This suggests that while diffuse intrinsic pontine glioma is a late onset disease in most patients, it represents an under-recognized disease in adults.

Anonymous Patient Answer

How does conventional or hypofractionated work?

Based on previous reports using 1.8-Gy fractionation and a very high RT-CBR, it is possible that the risk of acute and late toxicity may be higher for HIFN than for EF or RT alone.

Anonymous Patient Answer

Does conventional or hypofractionated improve quality of life for those with diffuse intrinsic pontine glioma?

Both radiation treatment modalities were associated with improvements in quality of life. Results from a recent paper may be explained by the reduction of symptoms in a high proportion of patients. Further improvement occurred after the initial course of post-relapse chemotherapy but not after the initial post-reimplant radiotherapy. This article is protected by copyright. All rights reserved.

Anonymous Patient Answer
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