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Motexafin Gadolinium and Radiation Therapy in Treating Young Patients With Pontine Glioma

Primary Purpose

Untreated Childhood Brain Stem Glioma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
motexafin gadolinium
3-dimensional conformal radiation therapy
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Untreated Childhood Brain Stem Glioma

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No prior definitive therapy for this specific tumor
  • No prior cranial radiotherapy
  • Concurrent steroids and anticonvulsants allowed
  • No concurrent proton therapy
  • No concurrent intensity-modulated radiotherapy
  • No concurrent anticancer chemotherapy
  • No concurrent immunomodulating agents

Sites / Locations

  • Children's Oncology Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

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.

Outcomes

Primary Outcome Measures

One Year Event-free Survival (EFS)
Percentage probability of being event-free at 1 year following enrollment.

Secondary Outcome Measures

Overall Survival (OS)
Percentage probability of being alive 1 year following enrollment.
The Number of Patients Who Experience at Least One Grade 3 or Higher CTC Version 4 Toxicity.
Occurrence of serious toxicity defined as any grade 4 hematologic toxicity that persists for more than 7 days or requires platelet transfusions for a time period exceeding 7 days; any grade 3 or 4 non-hematologic toxicity with the exception of grade 3 nausea or vomiting which can be controlled within 7 days; grade 3 skin reaction; grade 3 transaminitis.

Full Information

First Posted
October 12, 2006
Last Updated
December 6, 2017
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00387790
Brief Title
Motexafin Gadolinium and Radiation Therapy in Treating Young Patients With Pontine Glioma
Official Title
A Phase II Study of Motexafin-Gadolinium (NSC 695238, IND #55583) and Involved Field Radiation Therapy for Intrinsic Pontine Glioma of Childhood
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
Detailed Description
PRIMARY OBJECTIVES: I. Evaluate the effect of combining motexafin gadolinium with daily fractionated radiotherapy on 1-year event-free survival of pediatric patients with intrinsic pontine glioma (brain stem glioma). SECONDARY OBJECTIVES: I. Evaluate the effect of combining motexafin gadolinium with daily fractionated radiotherapy on 1-year overall survival of these patients. II. Determine the toxicities of motexafin gadolinium in combination with radiotherapy in these patients. OUTLINE: This is a multicenter study. 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. After completion of study treatment, patients are followed every 3 months for 3 years and then periodically thereafter.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Untreated Childhood Brain Stem Glioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
motexafin gadolinium
Other Intervention Name(s)
gadolinium texaphyrin, Gd (III) Texaphryin, Gd-Tex, PCI-0120, Xcytrin
Intervention Description
Given IV
Intervention Type
Radiation
Intervention Name(s)
3-dimensional conformal radiation therapy
Other Intervention Name(s)
3D conformal radiation therapy, 3D-CRT
Intervention Description
Undergo focal cranial radiotherapy
Primary Outcome Measure Information:
Title
One Year Event-free Survival (EFS)
Description
Percentage probability of being event-free at 1 year following enrollment.
Time Frame
One year after enrollment.
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Percentage probability of being alive 1 year following enrollment.
Time Frame
One year after enrollment.
Title
The Number of Patients Who Experience at Least One Grade 3 or Higher CTC Version 4 Toxicity.
Description
Occurrence of serious toxicity defined as any grade 4 hematologic toxicity that persists for more than 7 days or requires platelet transfusions for a time period exceeding 7 days; any grade 3 or 4 non-hematologic toxicity with the exception of grade 3 nausea or vomiting which can be controlled within 7 days; grade 3 skin reaction; grade 3 transaminitis.
Time Frame
One cycle of chemotherapy and radiation therapy; expected to be 42 days of treatment.

10. Eligibility

Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior definitive therapy for this specific tumor No prior cranial radiotherapy Concurrent steroids and anticonvulsants allowed No concurrent proton therapy No concurrent intensity-modulated radiotherapy No concurrent anticancer chemotherapy No concurrent immunomodulating agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin Bradley
Organizational Affiliation
Children's Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Oncology Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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Motexafin Gadolinium and Radiation Therapy in Treating Young Patients With Pontine Glioma

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