Phase I Brachytherapy Dose Escalation Using The GliaSite RTS In Newly Diagnosed Glioblastoma Multiforme In Conjunction With External Beam Radiation Therapy
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Locations
- 10
Study Overview
Brief Summary
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.
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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •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
- •Not specified
- •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
- •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
- +7 more not shown
Exclusion Criteria
- Not provided