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Brachytherapy in Treating Patients With Recurrent Malignant Glioma

Phase I Brachytherapy Dose Escalating Study Using the Proxima Therapeutics, Inc. GliaSite RTS in Patients With Recurrent Malignant Gliomas

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00045474
Enrollment
Unknown
Registered
2003-01-27
Start date
2002-10-31
Completion date
Unknown
Last updated
2009-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain and Central Nervous System Tumors

Keywords

adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult glioblastoma, recurrent adult brain tumor, adult giant cell glioblastoma, adult gliosarcoma

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. Patients are followed at 4 weeks and then every 2 months for 1 year. PROJECTED ACCRUAL: Approximately 20-30 patients will be accrued for this study.

Interventions

PROCEDUREadjuvant therapy
RADIATIONiodine I 125

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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: 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 * 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 Surgery * See Disease Characteristics * See Radiotherapy Other * Recovered from prior therapy * No prior investigational agents * No investigational agents during and for 90 days after study participation * Concurrent cytotoxic treatment allowed to improve quality of life

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026