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Motexafin Gadolinium Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma
This study has been completed.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Children's Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003909
  Purpose

RATIONALE: 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.

PURPOSE: 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
Brain and Central Nervous System Tumors
Drug: motexafin gadolinium
Radiation: radiation therapy
Phase I

MedlinePlus related topics: Cancer Radiation Therapy
Drug Information available for: Motexafin gadolinium Motexafin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I Study of Motexafin Gadolinium (Xcytrin, NSC 695238) and Involved Field Radiation Therapy for Intrinsic Pontine Glioma of Childhood

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

Study Start Date: August 1999
Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose (MTD) and schedule of motexafin gadolinium administered prior to radiotherapy in children with newly diagnosed diffuse intrinsic pontine glioma.
  • Determine the toxic effects of this drug given at the MTD in these patients.
  • Determine the intratumor and brain distribution of this drug by 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 maximum tolerated dose (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.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 21 and under

Performance status:

  • ECOG 0-2

Life expectancy:

  • More than 2 months

Hematopoietic:

  • 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

Hepatic:

  • Bilirubin no greater than 1.5 times normal
  • SGOT or SGPT less than 1.5 times normal

Renal:

  • Creatinine no greater than 1.5 times normal OR
  • Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent immunomodulating agents

Chemotherapy:

  • No other concurrent chemotherapy

Endocrine therapy:

  • Concurrent corticosteroid therapy allowed for increased intracranial pressure only

Radiotherapy:

  • No prior cranial radiotherapy

Surgery:

  • Not specified

Other:

  • No prior motexafin gadolinium
  • No other concurrent experimental agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003909

Locations
United States, California
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027-0700
Children's Hospital of Orange County
Orange, California, United States, 92868
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Stanford Cancer Center at Stanford University Medical Center
Palo Alto, California, United States, 94304-1812
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010-2970
United States, Georgia
MBCCOP-Medical College of Georgia Cancer Center
Augusta, Georgia, United States, 30912-4000
United States, Indiana
Riley's Children Cancer Center at Riley Hospital for Children
Indianapolis, Indiana, United States, 46202-5225
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
United States, New York
SUNY Upstate Medical University Hospital
Syracuse, New York, United States, 13210
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
United States, Pennsylvania
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
MBCCOP - South Texas Pediatrics
San Antonio, Texas, United States, 78229-3900
United States, Washington
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States, 98105
Australia, Western Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia, 6001
Canada, Ontario
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
Hopital Sainte Justine
Montreal, Quebec, Canada, H3T 1C5
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Minesh P. Mehta, MD University of Wisconsin, Madison
  More Information

Additional Information:
Publications:
Bradley KA, Pollack IF, Reid JM, Adamson PC, Ames MM, Vezina G, Blaney S, Ivy P, Zhou T, Krailo M, Reaman G, Mehta MP. Motexafin gadolinium and involved field radiation therapy for intrinsic pontine glioma of childhood: A Children's Oncology Group phase I study. Neuro Oncol. 2008 Aug 20; [Epub ahead of print]
Mehta MP, Forouzannia A, Ames M, et al.: Phase I study of Motexafin-Gadolinium (M-Gd) as a radiosensitizer for pediatric intrinsic pontine glioma (BSG): a Children Oncology Group Study. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-243, 2001.

Study ID Numbers: CDR0000067087, COG-A09712, CCG-09712
Study First Received: November 1, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00003909     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
untreated childhood brain stem glioma

Study placed in the following topic categories:
Neuroectodermal Tumors
Photosensitizing Agents
Brain Stem Glioma, Childhood
Radiation-Sensitizing Agents
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Glioma
Central Nervous System Neoplasms
Motexafin gadolinium
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Nervous System Diseases
Central Nervous System Neoplasms
Motexafin gadolinium
Pharmacologic Actions
Neuroectodermal Tumors
Photosensitizing Agents
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Glioma
Neoplasms, Neuroepithelial
Dermatologic Agents
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009