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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00387790
First received: October 12, 2006
Last updated: December 18, 2013
Last verified: December 2013

October 12, 2006
December 18, 2013
June 2007
April 2010   (final data collection date for primary outcome measure)
One Year Event-free Survival (EFS) [ Time Frame: Time to disease progression, disease relapse, occurrence of a second neoplasm, or death from any cause, assessed up to 1 year after enrollment. ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00387790 on ClinicalTrials.gov Archive Site
  • One Year Overall Survival [ Time Frame: Time to death from any cause, assessed up to 1 year after enrollment ] [ Designated as safety issue: No ]
  • Occurrence of Serious Toxicity [ Time Frame: Up to 1 year after enrollment ] [ Designated as safety issue: Yes ]
    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.
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Motexafin Gadolinium and Radiation Therapy in Treating Young Patients With Pontine Glioma
A PHASE II STUDY OF MOTEXAFIN-GADOLINIUM (NSC 695238, IND#55583) AND INVOLVED FIELD RADIATION THERAPY FOR INTRINSIC PONTINE GLIOMA OF CHILDHOOD

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

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 localized 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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Untreated Childhood Brain Stem Glioma
  • Drug: motexafin gadolinium
    Given IV
    Other Names:
    • gadolinium texaphyrin
    • Gd (III) Texaphryin
    • Gd-Tex
    • PCI-0120
    • Xcytrin
  • Radiation: 2-dimensional, 3-dimensional conformal, or intensity-modulated radiation therapy
    Undergo localized cranial radiotherapy
    Other Names:
    • 2D radiation therapy
    • 3D conformal radiation therapy
    • 3D-CRT
    • IMRT
Experimental: Radiation and motexafin gadolinium
Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo localized cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
Interventions:
  • Drug: motexafin gadolinium
  • Radiation: 2-dimensional, 3-dimensional conformal, or intensity-modulated radiation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
Not Provided
April 2010   (final data collection date for primary outcome measure)

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
    • Histology verification of malignancy is not required
  • 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 for post-menarchal females
  • Fertile patients must use effective contraception
  • No prior definitive therapy for this specific tumor
  • No prior cranial radiotherapy
  • Concurrent steroids and anticonvulsants allowed
  • Proton therapy not permitted
  • No concurrent anticancer chemotherapy
  • No concurrent immunomodulating agents
Both
up to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00387790
NCI-2012-01829, ACNS0222, U10CA098543, CDR0000504107, NCI-2012-01829
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Kristin Bradley Children's Oncology Group
National Cancer Institute (NCI)
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP