Motexafin Gadolinium and Radiation Therapy in Treating Young Patients With Pontine Glioma - Full Text View

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:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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:

MedlinePlus related topics: Cancer

Drug Information available for: Gadolinium

U.S. FDA Resources

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

Primary Outcome Measures:

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 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival [ Time Frame: Time to death from any cause, assessed up to 3 years ] [ Designated as safety issue: No ]

Enrollment:	60
Study Start Date:	June 2007
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

Ages Eligible for Study:	up to 21 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00387790

Locations

United States, California
Children's Oncology Group
Arcadia, California, United States, 91006-3776

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Kristin Bradley

Children's Oncology Group

More Information

No publications provided

Responsible Party:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00387790 History of Changes
Other Study ID Numbers:	NCI-2012-01829, ACNS0222, U10CA098543, CDR0000504107
Study First Received:	October 12, 2006
Last Updated:	February 6, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Glioma
Pontine Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

Astrocytoma
Motexafin gadolinium
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Dermatologic Agents

ClinicalTrials.gov processed this record on May 16, 2013