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


Phase 1
N/A
21 Years
Not Enrolling
Both
Untreated Childhood Brain Stem Glioma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

MTD defined as the dose at which fewer than one-third of patients experience DLT assessed using CTC version 2.0

Outcome Time Frame:

6 weeks

Safety Issue:

Yes

Principal Investigator

Minesh Mehta

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-01845

NCT ID:

NCT00003909

Start Date:

August 1999

Completion Date:

Related Keywords:

  • Untreated Childhood Brain Stem Glioma
  • Glioma

Name

Location

Children's Oncology GroupArcadia, California  91006-3776