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

Untreated Childhood Brain Stem Glioma Clinical Trial

Official title:

A Phase I Study of Motexafin Gadolinium (Xcytrin, NSC 695238) and Involved Field Radiation Therapy for Intrinsic Pontine Glioma of Childhood

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003909
• Other study ID #: NCI-2012-01845
• Secondary ID: COG-A09712U01CA0
• Status: Completed
• Phase: Phase 1
• First received: November 1, 1999
• Last updated: January 15, 2013
• Start date: August 1999

Study information

• Verified date: January 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioma
• Untreated Childhood Brain Stem Glioma

Intervention

Drug:
• motexafin gadolinium
Given IV

Radiation:
• radiation therapy
Undergo radiation therapy

Other:
• pharmacological study
Correlatives studies

Locations

Country	Name	City	State
United States	Children's Oncology Group	Arcadia	California

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MTD defined as the dose at which fewer than one-third of patients experience DLT assessed using CTC version 2.0		6 weeks	Yes