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Phase I Brachytherapy Dose Escalation Using The GliaSite RTS In Newly Diagnosed Glioblastoma Multiforme In Conjunction With External Beam Radiation Therapy


Phase 1
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

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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 InstituteTampa, Florida  33612
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
Abramson Cancer Center at University of Pennsylvania Medical CenterPhiladelphia, Pennsylvania  19104