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

NCT ID: NCT00003909

Last Updated: 2013-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-08-31

Brief Summary

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

Detailed Description

OBJECTIVES:

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.

Conditions

Untreated Childhood Brain Stem Glioma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

motexafin gadolinium

Intervention Type: DRUG

Given IV

radiation therapy

Intervention Type: RADIATION

Undergo radiation therapy

pharmacological study

Intervention Type: OTHER

Correlatives studies

Interventions

motexafin gadolinium

Given IV

Intervention Type: DRUG

radiation therapy

Undergo radiation therapy

Intervention Type: RADIATION

pharmacological study

Correlatives studies

Intervention Type: OTHER

Other Intervention Names

gadolinium texaphyrin; Gd (III) Texaphryin; Gd-Tex; PCI-0120; Xcytrin; irradiation; radiotherapy; therapy, radiation; pharmacological studies

Eligibility Criteria

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

• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Minesh Mehta

Role: PRINCIPAL_INVESTIGATOR

Children's Oncology Group

Locations

Children's Oncology Group

Arcadia, California, United States

Countries

United States

Other Identifiers

COG-A09712

Identifier Type: -

Identifier Source: secondary_id

U01CA097452

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000067087

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-01845

Identifier Type: -

Identifier Source: org_study_id