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Motexafin Gadolinium Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma
This study has been completed.
Study NCT00003909   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes

November 1, 1999
February 6, 2009
August 1999
 
 
 
Complete list of historical versions of study NCT00003909 on ClinicalTrials.gov Archive Site
 
 
 
Motexafin Gadolinium Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma
A Phase I Study of Motexafin Gadolinium (Xcytrin, NSC 695238) and Involved Field Radiation Therapy for Intrinsic Pontine Glioma of Childhood

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.

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.

Phase I
Interventional
Treatment
Brain and Central Nervous System Tumors
  • Drug: motexafin gadolinium
  • Radiation: radiation therapy
 
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]

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Both
up to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada
 
NCT00003909
 
CDR0000067087, COG-A09712, CCG-09712
Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: Minesh P. Mehta, MD University of Wisconsin, Madison
National Cancer Institute (NCI)
October 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP