Full Text View
Tabular View
No Study Results Posted
Related Studies
Motexafin Gadolinium Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma
This study has been completed.

First Received on November 1, 1999.   Last Updated on December 17, 2010   History of Changes
Sponsor: Children's Oncology Group
Collaborator: 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

Study Type: Interventional
Study Design: 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):

Study Start Date: August 1999
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
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

  Show 31 Study Locations
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.

ClinicalTrials.gov Identifier: NCT00003909     History of Changes
Other Study ID Numbers: CDR0000067087, COG-A09712, CCG-09712
Study First Received: November 1, 1999
Last Updated: December 17, 2010
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on February 09, 2012