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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00387790
First Posted: October 13, 2006
Last Update Posted: May 23, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
  Purpose
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.

Condition Intervention Phase
Untreated Childhood Brain Stem Glioma Drug: motexafin gadolinium Radiation: 3-dimensional conformal radiation therapy Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Motexafin-Gadolinium (NSC 695238, IND #55583) and Involved Field Radiation Therapy for Intrinsic Pontine Glioma of Childhood

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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. ]

Secondary Outcome Measures:
  • One Year Overall Survival [ Time Frame: Time to death from any cause, assessed up to 1 year after enrollment ]
  • Occurrence of Serious Toxicity [ Time Frame: Up to 1 year after enrollment ]
    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.


Enrollment: 64
Study Start Date: June 2007
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
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.
Drug: motexafin gadolinium
Given IV
Other Names:
  • gadolinium texaphyrin
  • Gd (III) Texaphryin
  • Gd-Tex
  • PCI-0120
  • Xcytrin
Radiation: 3-dimensional conformal radiation therapy
Undergo focal cranial radiotherapy
Other Names:
  • 3D conformal radiation therapy
  • 3D-CRT

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00387790


Locations
United States, Pennsylvania
Children's Oncology Group
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Kristin Bradley Children's Oncology Group
  More Information

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00387790     History of Changes
Other Study ID Numbers: NCI-2012-01829
NCI-2012-01829 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000504107
COG-ACNS0222
ACNS0222 ( Other Identifier: Children's Oncology Group )
ACNS0222 ( Other Identifier: CTEP )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: October 12, 2006
First Posted: October 13, 2006
Results First Submitted: December 18, 2013
Results First Posted: February 5, 2014
Last Update Posted: May 23, 2014
Last Verified: December 2012

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Motexafin gadolinium
Antineoplastic Agents
Photosensitizing Agents
Dermatologic Agents