Surgery Followed by Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00053183

Purpose

RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. External-beam radiation therapy uses high-energy x-rays to kill tumor cells. Combining internal radiation with external-beam radiation therapy may kill any remaining tumor cells following surgery.

PURPOSE: Phase I trial to study the effectiveness of combining internal radiation therapy with external-beam radiation therapy in treating patients who have undergone surgery for glioblastoma multiforme.

Condition	Intervention	Phase
Brain and Central Nervous System Tumors	Procedure: conventional surgery Radiation: brachytherapy Radiation: radiation therapy	Phase I

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	Phase I Brachytherapy Dose Escalation Using The GliaSite RTS In Newly Diagnosed Glioblastoma Multiforme In Conjunction With External Beam Radiation Therapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

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

Study Start Date:

October 2003

Detailed Description:

OBJECTIVES:

Determine the maximum tolerated dose of brachytherapy administered via GliaSite RTS™ applicator followed by external beam radiotherapy in patients with newly diagnosed glioblastoma multiforme.
Determine the acute and chronic toxicity of brachytherapy administered via GliaSite RTS™ in these patients.
Determine the survival rate of patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of brachytherapy.

Patients undergo craniotomy for histologic confirmation of glioblastoma multiforme, surgical resection, and placement of a GliaSite RTS™ applicator that includes Iotrex™.

Beginning 3-21 days after surgery, patients undergo brachytherapy via the GliaSite RTS™ applicator. Within 30 days of brachytherapy (no more than 60 days after resection) patients undergo external beam radiotherapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 5-10 patients receive escalating doses of brachytherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 5 or 3 of 10 patients experience dose-limiting toxicity.

Patients are followed at 21-35 days, every 2 months for 1 year, and then for survival.

PROJECTED ACCRUAL: A total of 15-100 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Clinically suspected supratentorial grade IV glioblastoma multiforme
Candidate for maximal surgical resection of tumor mass
- Expected residual enhancing tumor must be within the expected brachytherapy treatment volume
- Resection must not be expected to result in a new permanent neurologic deficit
No clearly multi-focal disease (2 or more separate foci of contrast-enhancing tumor not all within the expected brachytherapy prescription volume by MRI)
No enhancing tumor greater than 1 cm beyond the midline by MRI
No grossly or radiographically apparent leptomeningeal spread and/or ventricular invasion outside the anticipated radiation treatment volume
No marked edema by MRI with significant shift that is not anticipated to be corrected by resection

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Karnofsky 60-100%

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Hepatic

Not specified

Renal

Creatinine no greater than 1.7 mg/dL
BUN no greater than 2 times upper limit of normal

Cardiovascular

No uncontrolled hypertension
No unstable angina pectoris
No uncontrolled cardiac dysrhythmia

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Mini mental state exam score at least 15
No other concurrent medical illness that would preclude study participation
No concurrent serious infection
No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

No immunotherapy prior to, during, or within 90 days after brachytherapy
No biologic therapy with any of the following prior to, during, or within 90 days after brachytherapy :
- Immunotoxins
- Immunoconjugates
- Antiangiogenesis compounds
- Peptide receptor antagonists
- Interferons
- Interleukins
- Tumor-infiltrating lymphocytes
- Lymphokine-activated killer cells
- Gene therapy
- Antisense agents

Chemotherapy

No chemotherapy or polifeprosan 20 with carmustine implant (Gliadel wafers) prior to, during, or within 90 days after brachytherapy

Endocrine therapy

No hormonal therapy prior to, during, or within 90 days after brachytherapy
Concurrent corticosteroids to improve quality of life allowed

Radiotherapy

No other radiotherapy prior to, during, or within 90 days after brachytherapy

Surgery

See Disease Characteristics
No radiosurgery prior to, during, or within 90 days after brachytherapy

Other

No other investigational agents directed at the brain tumor prior to, during, or within 90 days after brachytherapy
Concurrent noncytotoxic therapy to improve quality of life allowed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00053183

Locations

United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3295
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
United States, Georgia
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
United States, Michigan
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, North Carolina
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Abramson Cancer Center at University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284-7811

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair:

Volker W. Stieber, MD

Comprehensive Cancer Center of Wake Forest University

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

ClinicalTrials.gov Identifier:	NCT00053183 History of Changes
Other Study ID Numbers:	CDR0000269300, NABTT-2105, JHOC-NABTT-2105
Study First Received:	January 27, 2003
Last Updated:	February 6, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:

Glioblastoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors

Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on February 12, 2012