NCT00387790

Brief Summary

This phase II trial is studying how well giving motexafin gadolinium together with radiation therapy works in treating young patients with pontine glioma. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as motexafin gadolinium, may make tumor cells more sensitive to radiation therapy. Giving motexafin gadolinium together with radiation therapy may kill more tumor cells.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2007

Typical duration for phase_2

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

First Submitted

Initial submission to the registry

October 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2006

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

February 5, 2014

Completed
Last Updated

January 4, 2018

Status Verified

December 1, 2017

Enrollment Period

2.8 years

First QC Date

October 12, 2006

Results QC Date

December 18, 2013

Last Update Submit

December 6, 2017

Conditions

Untreated Childhood Brain Stem Glioma

Outcome Measures

Primary Outcomes (1)

  • One Year Event-free Survival (EFS)

    Percentage probability of being event-free at 1 year following enrollment.

    One year after enrollment.

Secondary Outcomes (2)

  • Overall Survival (OS)

    One year after enrollment.

  • The Number of Patients Who Experience at Least One Grade 3 or Higher CTC Version 4 Toxicity.

    One cycle of chemotherapy and radiation therapy; expected to be 42 days of treatment.

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo focal cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

Drug: motexafin gadoliniumRadiation: 3-dimensional conformal radiation therapy

Interventions

motexafin gadoliniumDRUG

Given IV

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

Undergo focal cranial radiotherapy

Also known as: 3D conformal radiation therapy, 3D-CRT
Arm I

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of intrinsic pontine glioma (brain stem glioma)
  • Clinical and radiographic (MRI) evidence of tumors that diffusely involve the brain stem (i.e., tumors that intrinsically \[\> 50% intra-axial\] involve the pons or pons and medulla, pons and midbrain, or entire brain stem) allowed
  • Tumor may contiguously involve the thalamus or upper cervical cord
  • No more than 1 lesion/mass present at diagnosis
  • Karnofsky performance status (PS) 60-100% (age \> 16 years) OR Lansky PS 60-100% (age ≤ 16 years)
  • Life expectancy ≥ 8 weeks
  • Absolute neutrophil count ≥ 1,000/mm³
  • Platelet count ≥ 100,000/mm³ (transfusion independent)
  • Hemoglobin ≥ 10 g/dL (RBC transfusions allowed)
  • Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR creatinine normal for age/gender (0.4-1.7 mg/dL)
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT \< 1.5 times ULN
  • No known glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • If family history suggestive of congenital hemolytic anemia, patient must be screened for G6PD with G6PD activity test prior to study entry
  • No biliary obstruction
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Oncology Group

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

motexafin gadoliniumRadiotherapy, Conformal

Intervention Hierarchy (Ancestors)

Radiotherapy, Computer-AssistedRadiotherapyTherapeutics

Results Point of Contact

Title
Results Reporting Coordinator
Organization
Children's Oncology Group
resultsreportingcoordinator@childrensoncologygroup.org
352-273-0558

Study Officials

  • Kristin Bradley

    Children's Oncology Group

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2006

First Posted

October 13, 2006

Study Start

June 1, 2007

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

January 4, 2018

Results First Posted

February 5, 2014

Record last verified: 2017-12

Locations

US(1)