Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	21 and under	NCI	COG-A09712 CCG-09712, NCT00003909, A09712

Objectives

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

Entry 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

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

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/mm³
• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

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

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.

Bradley KA, Pollack IF, Reid JM, et al.: Motexafin gadolinium and involved field radiation therapy for intrinsic pontine glioma of childhood: a Children's Oncology Group phase I study. Neuro Oncol 10 (5): 752-8, 2008.[PUBMED Abstract]

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.

Trial Contact Information

Trial Lead Organizations

Children's Oncology Group

Minesh Mehta, MD, Protocol chair		Ph: 608-263-5009; 800-622-8922 Email: mehta@humonc.wisc.edu

Registry Information
Official Title		A Phase I Study of Motexafin Gadolinium (Xcytrin, NSC 695238) and Involved Field Radiation Therapy for Intrinsic Pontine Glioma of Childhood
Trial Start Date		1999-08-23
Registered in ClinicalTrials.gov		NCT00003909
Date Submitted to PDQ		1999-05-27
Information Last Verified		2005-10-18
NCI Grant/Contract Number		CA13539

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