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A PHASE II STUDY OF MOTEXAFIN-GADOLINIUM (NSC 695238, IND #55583) AND INVOLVED FIELD RADIATION THERAPY FOR INTRINSIC PONTINE GLIOMA OF CHILDHOOD


Phase 2
N/A
21 Years
Not Enrolling
Both
Untreated Childhood Brain Stem Glioma

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Trial Information

A PHASE II STUDY OF MOTEXAFIN-GADOLINIUM (NSC 695238, IND #55583) AND INVOLVED FIELD RADIATION THERAPY FOR INTRINSIC PONTINE GLIOMA OF CHILDHOOD


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Event-free survival (EFS)

Outcome Time Frame:

Time to disease progression, disease relapse, occurrence of a second neoplasm, or death from any cause, assessed up to 3 years

Safety Issue:

No

Principal Investigator

Kristin Bradley

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-01829

NCT ID:

NCT00387790

Start Date:

June 2007

Completion Date:

Related Keywords:

  • Untreated Childhood Brain Stem Glioma
  • Glioma
  • Pontine Glioma

Name

Location
Children's Oncology Group Arcadia, California  91006-3776