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

Sponsor:	Children's Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00387790

Purpose

RATIONALE: 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.

PURPOSE: This phase II trial is studying how well giving motexafin gadolinium together with radiation therapy works in treating young patients with pontine glioma.

Condition	Intervention	Phase
Brain and Central Nervous System Tumors	Drug: motexafin gadolinium Radiation: radiation therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
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: Motexafin gadolinium Motexafin

U.S. FDA Resources

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

Primary Outcome Measures:

Event-free survival, defined as time to disease progression, disease relapse, occurrence of second neoplasm, or death from any cause at 1 year [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival, defined as time to death from any cause at 1 year [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	June 2007
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

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

Evaluate the effect of combining motexafin gadolinium with daily fractionated radiotherapy on 1-year overall survival of these patients.
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.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	up to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

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

PRIOR CONCURRENT THERAPY:

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

Show 93 Study Locations

Sponsors and Collaborators

Children's Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Kristin A. Bradley, MD

University of Wisconsin, Madison

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Children's Oncology Group - Group Chair Office ( Gregory H. Reaman )
Study ID Numbers:	CDR0000504107, COG-ACNS0222
Study First Received:	October 12, 2006
Last Updated:	April 14, 2009
ClinicalTrials.gov Identifier:	NCT00387790 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

untreated childhood brain stem glioma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Nervous System Diseases
Central Nervous System Neoplasms
Motexafin gadolinium
Pharmacologic Actions
Neuroectodermal Tumors
Photosensitizing Agents

Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Glioma
Neoplasms, Neuroepithelial
Dermatologic Agents
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 20, 2009