NCT00045474CompletedPhase 1
Phase I Brachytherapy Dose Escalating Study Using the Proxima Therapeutics, Inc. GliaSite RTS in Patients With Recurrent Malignant Gliomas
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Locations
- 9
Study Overview
Brief Summary
RATIONALE: Brachytherapy uses radioactive material to kill cancer cells remaining after surgery.
PURPOSE: Phase I trial to study the effectiveness of brachytherapy in treating patients who have recurrent malignant glioma.
Detailed Description
OBJECTIVES:
- Determine the maximum tolerated dose of brachytherapy using an intracavitary applicator and liquid iodine I 125 in patients with recurrent malignant glioma.
- Determine the acute and chronic toxicity of this therapy in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Within 3-21 days after surgical resection, patients receive brachytherapy using an intracavity balloon application (GliaSite) with iodine I 125 solution for a total of 5-7 days.
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 10 patients experience dose-limiting 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:
- •Histologically confirmed malignant glioma
- •Anaplastic astrocytoma, anaplastic oligodendroglioma, or glioblastoma multiforme
- •Low-grade astrocytoma that progresses to high-grade astrocytoma allowed
- •Unifocal disease
- •Progressive or recurrent after radiotherapy with or without chemotherapy
- •Previously treated with at least 5,000 cGy external beam radiotherapy more than 3 months ago
- •Candidate for maximal surgical resection
- •Any expected residual enhancing tumor must be within expected brachytherapy treatment volume
- •Resection must not be expected to result in a new permanent neurologic deficit
- •No tumor crossing more than 1 cm beyond the midline on preoperative MRI or CT scan
- •No grossly or radiographically apparent leptomeningeal spread
- •No ventricular invasion outside the anticipated radiotherapy treatment volume
- •No marked edema on MRI or CT scan
- •Patients with 2 or more separate foci of contrast-enhancing tumors that are more than 5 cm apart on preoperative MRI or CT scan are ineligible
- •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
- •Mini mental score at least 15
- •No other medical illness that would preclude study participation
- •No serious infection
- •No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent immunotherapy
- •No concurrent biologic agents (e.g., immunotoxins, immunoconjugates, antiangiogenesis compounds, antisense therapy, peptide receptor antagonists, interferons, interleukins, tumor-infiltrating lymphocytes, lymphokine-activated killer cells, or gene therapy)
- •Chemotherapy
- •See Disease Characteristics
- •At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)
- •No concurrent polifeprosan 20 with carmustine implant (Gliadel wafer)
- •Endocrine therapy
- •Concurrent corticosteroids allowed to improve quality of life
- •Radiotherapy
- •See Disease Characteristics
- •No concurrent radiosurgery
- +6 more not shown
Exclusion Criteria
- Not provided
Investigators
Study Sites (9)
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