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Intra-arterial Chemotherapy for the Treatment of Progressive Diffuse Intrinsic Pontine Gliomas (DIPG).


Phase 1
1 Month
17 Years
Not Enrolling
Both
Diffuse Intrinsic Pontine Glioma (DIPG)

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Trial Information

Intra-arterial Chemotherapy for the Treatment of Progressive Diffuse Intrinsic Pontine Gliomas (DIPG).


Delivering the chemotherapeutic agent directly to the tumor via the arterial system avoids
the complications and adverse events associated with toxicity from systemic chemotherapy.


Inclusion Criteria:



- Pediatric patients of all ages with progressive DIPG.

- Consensus following presentation of the case at the multidisciplinary Pediatric
Neuro-Oncology conference, which includes participation of neuro-oncology,
neurosurgery, radiation oncology, interventional neuroradiology and neurology.

Exclusion Criteria:

- Documented hypercoagulable disorders or vasculopathies

- INR value more than a Grade 1 toxicity by CTCAE v 4.0 criteria (>1 - 1.5 x ULN;
>1 - 1.5 times above baseline if on anticoagulation).

- APTT value more than a Grade 1 toxicity by CTCAE v 4.0 criteria (>ULN - 1.5 x
ULN).

- Platelets less than 50 x 103/mm3

- Absolute neutrophil count less than 500/ mm3

- Pregnancy

- Documented severe allergic reaction to IV iodinated contrast, specifically
bronchospasm and anaphylaxis.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Technical safety

Outcome Description:

In this feasibility study, we are going to perform a qualitative evaluation of whether or not we can safely deliver IA chemotherapy to patients with progressive DIPG. Assessment of non-hematologic toxicity will include grading according to the Nervous system disorder CTCAE, specifically grades 3-5 intracranial hemorrhage and grades 3-5 stroke. Note will be made if the patient requires a blood transfusion.

Outcome Time Frame:

60 days

Safety Issue:

Yes

Principal Investigator

Monica Pearl, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Johns Hopkins Hospital

Authority:

United States: Food and Drug Administration

Study ID:

J11164

NCT ID:

NCT01688401

Start Date:

January 2013

Completion Date:

Related Keywords:

  • Diffuse Intrinsic Pontine Glioma (DIPG)
  • diffuse intrinsic pontine glioma (DIPG)
  • intra-arterial chemotherapy
  • angiography
  • Glioma
  • Pontine Glioma

Name

Location

The Johns Hopkins HospitalBaltimore, Maryland  21205