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

Untreated Childhood Brain Stem Glioma Clinical Trial

Official title:

A Phase II Study of Motexafin-Gadolinium (NSC 695238, IND #55583) and Involved Field Radiation Therapy for Intrinsic Pontine Glioma of Childhood

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00387790
• Other study ID #: NCI-2012-01829
• Secondary ID: NCI-2012-01829CD
• Status: Completed
• Phase: Phase 2
• First received: October 12, 2006
• Last updated: December 6, 2017
• Start date: June 2007
• Est. completion date: April 2010

Study information

• Verified date: December 2017
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Glioma
• Untreated Childhood Brain Stem Glioma

Intervention

Drug:
• motexafin gadolinium
Given IV

Radiation:
• 3-dimensional conformal radiation therapy
Undergo focal cranial radiotherapy

Locations

Country	Name	City	State
United States	Children's Oncology Group	Philadelphia	Pennsylvania

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	One Year Event-free Survival (EFS)	Percentage probability of being event-free at 1 year following enrollment.	One year after enrollment.
Secondary	Overall Survival (OS)	Percentage probability of being alive 1 year following enrollment.	One year after enrollment.
Secondary	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.	One cycle of chemotherapy and radiation therapy; expected to be 42 days of treatment.