Phase I Brachytherapy Dose Escalation Using The GliaSite RTS In Newly Diagnosed Glioblastoma Multiforme In Conjunction With External Beam Radiation Therapy
18 Years
N/A
Both
Brain and Central Nervous System Tumors
Trial Information
Phase I Brachytherapy Dose Escalation Using The GliaSite RTS In Newly Diagnosed Glioblastoma Multiforme In Conjunction With External Beam Radiation Therapy
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Volker W. Stieber, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Comprehensive Cancer Center of Wake Forest University
Authority:
United States: Federal Government
Study ID:
CDR0000269300
NCT ID:
NCT00053183
Start Date:
October 2003
Completion Date:
Related Keywords:
- Brain and Central Nervous System Tumors
- adult glioblastoma
- adult giant cell glioblastoma
- adult gliosarcoma
- Glioblastoma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
Name | Location |
|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
| University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
| Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
| University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
| Winship Cancer Institute of Emory University | Atlanta, Georgia 30322 |
| Abramson Cancer Center at University of Pennsylvania Medical Center | Philadelphia, Pennsylvania 19104 |
