A PHASE II STUDY OF MOTEXAFIN-GADOLINIUM (NSC 695238, IND #55583) AND INVOLVED FIELD RADIATION THERAPY FOR INTRINSIC PONTINE GLIOMA OF CHILDHOOD
N/A
21 Years
Both
Untreated Childhood Brain Stem Glioma
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 |
