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

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ClinicalTrials.gov Identifier: NCT01688401
Recruitment Status : Completed
First Posted : September 19, 2012
Last Update Posted : March 28, 2019
Sponsor:
Collaborator:
Solving Kids’ Cancer
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:
The goal of this pilot study is to determine if intra-arterial (IA) chemotherapy is safe in the treatment of progressive diffuse intrinsic pontine gliomas (DIPG). IA administration of the chemotherapeutic agent enhances the regional distribution of the drug, thereby increasing the local delivered dose while minimizing systemic toxicity. It also provides a treatment option for these patients at the time of tumor recurrence.

Condition or disease Intervention/treatment Phase
Diffuse Intrinsic Pontine Glioma (DIPG) Drug: Melphalan hydrochloride Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Intra-arterial Chemotherapy for the Treatment of Progressive Diffuse Intrinsic Pontine Gliomas (DIPG).
Actual Study Start Date : March 8, 2013
Actual Primary Completion Date : May 2017
Actual Study Completion Date : November 26, 2018


Arm Intervention/treatment
Experimental: IA melphalan
IA melphalan is administered via the basilar artery.
Drug: Melphalan hydrochloride

Drug administered intra-arterially (injection in the artery).

Standard dose: Cycle 1: 1 mg, intra-arterial (IA) delivery. Cycle 2: 2 mg, intra-arterial (IA) delivery.

Duration of treatment: Eight weeks total - two cycles of IA chemotherapy, separated by four weeks.

Other Name: Alkeran




Primary Outcome Measures :
  1. Technical safety as determined by number of participants with toxicity [ Time Frame: 60 days ]
    Number of participants with grades 3-5 intracranial hemorrhage, grades 3-5 stroke, as defined by the Nervous system disorder CTCAE, and requirement of blood transfusion.


Secondary Outcome Measures :
  1. Long-term Efficacy as assessed by progression free survival [ Time Frame: 2 years ]
    Number of months until disease progression.


Other Outcome Measures:
  1. Immediate Efficacy as assessed by number of participants with decrease in required steroid dose [ Time Frame: 60 days ]
  2. Immediate Efficacy as assessed by number of participants with decrease in tumor size on MRI [ Time Frame: 60 days ]
  3. Immediate Efficacy as assessed by number of participants with decrease in the degree of enhancement on MRI [ Time Frame: 60 days ]
  4. Immediate Efficacy as assessed by number of participants with improved neurological examination [ Time Frame: 60 days ]


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Ages Eligible for Study:   1 Month to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT01688401


Locations
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United States, Maryland
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Solving Kids’ Cancer
Investigators
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Principal Investigator: Monica Pearl, M.D. Johns Hopkins University

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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT01688401     History of Changes
Other Study ID Numbers: J11164
NA_00069122 ( Other Identifier: JHMIRB )
First Posted: September 19, 2012    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019

Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
diffuse intrinsic pontine glioma (DIPG)
intra-arterial chemotherapy
angiography

Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Melphalan
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs