NCT00003909

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1999

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

7.6 years

First QC Date

November 1, 1999

Last Update Submit

January 15, 2013

Conditions

Untreated Childhood Brain Stem Glioma

Outcome Measures

Primary Outcomes (1)

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

    6 weeks

Study Arms (1)

Arm I

EXPERIMENTAL

Approximately 2-5 hours before radiotherapy, patients receive motexafin gadolinium IV over 5 minutes. Patients undergo radiotherapy 5 days a week for 6 weeks.

Drug: motexafin gadoliniumRadiation: radiation therapyOther: pharmacological study

Interventions

motexafin gadoliniumDRUG

Given IV

Also known as: gadolinium texaphyrin, Gd (III) Texaphryin, Gd-Tex, PCI-0120, Xcytrin
Arm I
radiation therapyRADIATION

Undergo radiation therapy

Also known as: irradiation, radiotherapy, therapy, radiation
Arm I
pharmacological studyOTHER

Correlatives studies

Also known as: pharmacological studies
Arm I

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Oncology Group

Arcadia, California, 91006-3776, United States

Location

MeSH Terms

Interventions

motexafin gadoliniumRadiotherapyRadiation

Intervention Hierarchy (Ancestors)

TherapeuticsPhysical Phenomena

Study Officials

  • Minesh Mehta

    Children's Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

August 1, 1999

Primary Completion

March 1, 2007

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations

US(1)