Clinical trial NCT00387790: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Untreated Childhood Brain Stem Glioma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2006-10-13
Enrollment: 64
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: One Year Event-free Survival (EFS)
timeFrame: One year after enrollment.
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: One year after enrollment.
measure: The Number of Patients Who Experience at Least One Grade 3 or Higher CTC Version 4 Toxicity.
timeFrame: One cycle of chemotherapy and radiation therapy; expected to be 42 days of treatment.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Oncology Group
state: Pennsylvania
Study officials:
affiliation: Children's Oncology Group
name: Kristin Bradley
role: PRINCIPAL_INVESTIGATOR
References: