Brachytherapy in Treating Patients With Recurrent Malignant Glioma
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Procedure: adjuvant therapy Radiation: iodine I 125 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase I Brachytherapy Dose Escalating Study Using the Proxima Therapeutics, Inc. GliaSite RTS in Patients With Recurrent Malignant Gliomas |
| Study Start Date: | October 2002 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Alabama | |
| University of Alabama at Birmingham Comprehensive Cancer Center | |
| Birmingham, Alabama, United States, 35294-3295 | |
| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute | |
| Tampa, Florida, United States, 33612-9497 | |
| United States, Georgia | |
| Winship Cancer Institute of Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
| United States, Massachusetts | |
| Massachusetts General Hospital Cancer Center | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Michigan | |
| Josephine Ford Cancer Center at Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| United States, North Carolina | |
| Comprehensive Cancer Center at Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157-1030 | |
| United States, Ohio | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Pennsylvania | |
| Abramson Cancer Center at University of Pennsylvania Medical Center | |
| Philadelphia, Pennsylvania, United States, 19104-4283 | |
| Study Chair: | Larry Kleinberg, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00045474 History of Changes |
| Other Study ID Numbers: | CDR0000256587, NABTT-2106, JHOC-NABTT-2106 |
| Study First Received: | September 6, 2002 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
adult anaplastic astrocytoma adult anaplastic oligodendroglioma adult glioblastoma |
recurrent adult brain tumor adult giant cell glioblastoma adult gliosarcoma |
Additional relevant MeSH terms:
|
Nervous System Neoplasms Central Nervous System Neoplasms Glioma Neoplasms by Site Neoplasms Nervous System Diseases Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Iodine Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 13, 2013