Expired Study
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Los Angeles, California 90095


Purpose:

RATIONALE: New imaging procedures such as magnetic resonance imaging may improve the ability to determine the growth rate of progressive astrocytoma. PURPOSE: Phase II trial to study the effectiveness of magnetic resonance imaging in treating children who have progressive low-grade astrocytoma.


Study summary:

OBJECTIVES: I. Determine if tumor growth rate can be decreased by targeting areas of increased choline activity, as measured by magnetic resonance spectroscopic imaging, in pediatric patients with progressive low grade astrocytoma treated with surgical resection and/or focal radiotherapy. II. Improve the quality of life without use of aggressive surgery or radiotherapy in this patient population. OUTLINE: Patients undergo magnetic resonance spectroscopic imaging (MRSI) over 60 minutes prior to surgery and/or radiotherapy. Patients are assigned to one of two treatment arms based on tumor accessibility and may crossover to either arm. Arm I: Patients undergo conventional surgery. Arm II: Patients with inaccessible tumors undergo focal radiotherapy. Following surgery and/or radiotherapy, patients are followed every 4 months for up to 2 years with MRSI or MRI for tumor response and growth. PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study over 2 years.


Criteria:

DISEASE CHARACTERISTICS: Diagnosis of low grade astrocytoma in the hypothalamus, brain stem, or thalamus of 5 cm on T2 weighted scans Incomplete surgical resection Previously treated with evidence of tumor progression No hemispheric or cerebellar masses PATIENT CHARACTERISTICS: Age: 12 and under Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified PRIOR CONCURRENT THERAPY: See Disease Characteristics


Study is Available At:


Original ID:

CDR0000067693


NCT ID:

NCT00005084


Secondary ID:

UCLA-9702077


Study Acronym:


Brief Title:

Magnetic Resonance Imaging in Treating Children With Progressive Low-Grade Astrocytoma


Official Title:

Pediatric Low Grade Astrocytoma: Treatment Guidance


Overall Status:

Active, not recruiting


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

N/A


Maximum Age:

12 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

24


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Jeffry Alger, PhD
Study Chair
Jonsson Comprehensive Cancer Center

Study Dates

Start Date:February 1999
Verification Date:February 2008
Last Changed Date:December 17, 2013
First Received Date:April 6, 2000

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Procedure
Name:conventional surgery
Intervention Type:Procedure
Name:magnetic resonance spectroscopic imaging
Intervention Type:Radiation
Name:radiation therapy

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Jonsson Comprehensive Cancer Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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