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Motexafin Gadolinium Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma

This study has been completed.
Information provided by (Responsible Party):
National Cancer Institute (NCI) Identifier:
First received: November 1, 1999
Last updated: January 15, 2013
Last verified: January 2013
Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as motexafin gadolinium may make the tumor cells more sensitive to radiation therapy. Phase I trial to study the effectiveness of motexafin gadolinium plus radiation therapy in treating children who have newly diagnosed brain stem glioma

Condition Intervention Phase
Untreated Childhood Brain Stem Glioma
Drug: motexafin gadolinium
Radiation: radiation therapy
Other: pharmacological study
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Motexafin Gadolinium (Xcytrin, NSC 695238) and Involved Field Radiation Therapy for Intrinsic Pontine Glioma of Childhood

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • MTD defined as the dose at which fewer than one-third of patients experience DLT assessed using CTC version 2.0 [ Time Frame: 6 weeks ]

Enrollment: 24
Study Start Date: August 1999
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Approximately 2-5 hours before radiotherapy, patients receive motexafin gadolinium IV over 5 minutes. Patients undergo radiotherapy 5 days a week for 6 weeks.
Drug: motexafin gadolinium
Given IV
Other Names:
  • gadolinium texaphyrin
  • Gd (III) Texaphryin
  • Gd-Tex
  • PCI-0120
  • Xcytrin
Radiation: radiation therapy
Undergo radiation therapy
Other Names:
  • irradiation
  • radiotherapy
  • therapy, radiation
Other: pharmacological study
Correlatives studies
Other Name: pharmacological studies

Detailed Description:


I. Determine the maximum tolerated dose (MTD) and schedule of motexafin gadolinium administered prior to radiotherapy in children with newly diagnosed diffuse intrinsic pontine glioma.

II. Determine the toxic effects of this drug given at the MTD in these patients.

III. Determine the intratumor and brain distribution of this drug by magnetic resonance imaging (MRI) in these patients.

OUTLINE: This is a dose-escalation study of motexafin gadolinium.

Approximately 2-5 hours before radiotherapy, patients receive motexafin gadolinium IV over 5 minutes. Patients undergo radiotherapy 5 days a week for 6 weeks.

Cohorts of 3-6 patients receive escalating doses of motexafin gadolinium until the MTD is determined. The first cohort receives motexafin gadolinium 5 days a week for 3 weeks; the second cohort receives motexafin gadolinium 3 days a week for 6 weeks; and subsequent cohorts receive motexafin gadolinium 5 days a week for 6 weeks. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 3 months for up to 3 years.

PROJECTED ACCRUAL: A maximum of 24 patients will be accrued for this study within 2 years.


Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinically and radiographically (MRI) proven newly diagnosed diffuse intrinsic brainstem glioma

    • Greater than 50% intra-axial involvement of the pons, pons and medulla, pons and midbrain, or entire brainstem
    • Contiguous involvement of the thalamus or upper cervical cord allowed
  • Performance status - ECOG 0-2
  • More than 2 months
  • Absolute neutrophil count at least 1,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10.0 g/dL (transfusion allowed)
  • No glucose 6 phosphate dehydrogenase deficiency
  • Bilirubin no greater than 1.5 times normal
  • SGOT or SGPT less than 1.5 times normal
  • Creatinine no greater than 1.5 times normal
  • Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No concurrent immunomodulating agents
  • No other concurrent chemotherapy
  • Concurrent corticosteroid therapy allowed for increased intracranial pressure only
  • No prior cranial radiotherapy
  • No prior motexafin gadolinium
  • No other concurrent experimental agents
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Please refer to this study by its identifier: NCT00003909

United States, California
Children's Oncology Group
Arcadia, California, United States, 91006-3776
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Minesh Mehta Children's Oncology Group
  More Information

Responsible Party: National Cancer Institute (NCI) Identifier: NCT00003909     History of Changes
Other Study ID Numbers: NCI-2012-01845
U01CA097452 ( US NIH Grant/Contract Award Number )
CDR0000067087 ( Registry Identifier: PDQ (Physician Data Query) )
Study First Received: November 1, 1999
Last Updated: January 15, 2013

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Motexafin gadolinium
Antineoplastic Agents
Photosensitizing Agents
Dermatologic Agents processed this record on April 26, 2017