Trial record 3 of 4 for:    terezakis

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Sidney Kimmel Comprehensive Cancer Center
Sponsor:
Collaborator:
Solving Kids’ Cancer
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01688401
First received: September 10, 2012
Last updated: August 22, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Diffuse Intrinsic Pontine Glioma (DIPG)
Drug: Melphalan hydrochloride
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Intra-arterial Chemotherapy for the Treatment of Progressive Diffuse Intrinsic Pontine Gliomas (DIPG).

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Technical safety [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]

    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.



Secondary Outcome Measures:
  • Efficacy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Analysis of long-term efficacy will be made by assessing progression free survival in terms of months.


Other Outcome Measures:
  • Efficacy [ Time Frame: 60 days ] [ Designated as safety issue: No ]
    Analysis of immediate efficacy will be made by assessing for signs of tumor response as evidenced by a decrease in required steroid dose.

  • Efficacy [ Time Frame: 60 days ] [ Designated as safety issue: No ]
    Analysis of immediate efficacy will be made by assessing for signs of tumor response as evidenced by a decrease in tumor size on MRI.

  • Efficacy [ Time Frame: 60 days ] [ Designated as safety issue: No ]
    Analysis of immediate efficacy will be made by assessing for signs of tumor response as evidenced by a decrease in the degree of enhancement on MRI.

  • Efficacy [ Time Frame: 60 days ] [ Designated as safety issue: No ]
    Analysis of immediate efficacy will be made by assessing for signs of tumor response as evidenced by an improved neurologic examination.


Estimated Enrollment: 5
Study Start Date: January 2013
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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.

  Eligibility

Ages Eligible for Study:   1 Month to 17 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01688401

Contacts
Contact: Monica Pearl, M.D. 410-955-8525 msmit135@jhmi.edu
Contact: Amber Jones, B.A., CCRP 410-502-0736 ajones78@jhmi.edu

Locations
United States, Maryland
The Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Sub-Investigator: Ken Cohen, M.D., MBA         
Sub-Investigator: Eric Raabe, M.D., Ph.D         
Sub-Investigator: Stephanie Terezakis, M.D.         
Sub-Investigator: George Jallo, M.D.         
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Solving Kids’ Cancer
Investigators
Principal Investigator: Monica Pearl, M.D. The Johns Hopkins Hospital
  More Information

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01688401     History of Changes
Other Study ID Numbers: J11164, NA_00069122
Study First Received: September 10, 2012
Last Updated: August 22, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
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
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014