Clinical trial NCT00003574: Radiation Therapy in Treating Patients With Progressive or Recurrent Malignant Brain Tumors
Official title: A Multi-Center, Open-Label Clinical Study to Evaluate the Safety and Performance of the Proxima GliaSite RTS, a Radiation Delivery System, in Patients With Recurrent Malignant Brain Tumors Undergoing Surgical Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Brain and Central Nervous System Tumors
Keywords: recurrent adult brain tumor
adult glioblastoma
adult anaplastic astrocytoma
adult anaplastic oligodendroglioma
adult giant cell glioblastoma
adult gliosarcoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-06-16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of radiation therapy in treating patients who are undergoing surgical removal of progressive or recurrent malignant brain tumors.

Detailed description: OBJECTIVES: I. Evaluate the safety of the GliaSite RTS in patients with progressive or recurrent malignant brain tumors undergoing surgical resection. II. Evaluate the performance of the GliaSite RTS in these patients.

OUTLINE: This is an open label, multicenter study. Patients undergo surgical resection of the tumor followed by surgical placement of the GliaSite device in the resection cavity. One to 2 weeks after surgery, patients receive brachytherapy consisting of an infusion of iodine I-125. The I-125 solution is removed and collected 5-7 days later. The device is surgically removed within 24 hours. Patients are followed at 24 hours, 14 days, and 1 year post device removal.

PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS: Histologically confirmed malignant glioma: Anaplastic astrocytoma Anaplastic oligodendroglioma Glioblastoma multiforme Unifocal disease Progressive or recurrent disease following radiation therapy and/or chemotherapy Must be eligible for surgical resection of the tumor mass No unresectable leptomeningeal spread or ventricular invasion outside the radiation treatment volume No exophytic ventricular tumors Must have a maximal cross-sectional diameter enhancing tumor greater than 2.0 cm but not greater than 5.0 cm by preoperative MRI Ratio of major axes of the tumor should not exceed 1.5 No marked edema by preoperative MRI or CT that cannot be corrected by tumor resection

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Greater than 3 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No uncontrolled hypertension, angina pectoris, or uncontrolled cardiac dysrhythmia Other: Not pregnant or nursing Fertile patients must use effective contraception No serious concurrent infection or other medical illness No prior or concurrent malignancy within 5 years except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma of the skin

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy: See Disease Characteristics No concurrent chemotherapy At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas) and recovered Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 3 months since prior radiotherapy and recovered Surgery: See Disease Characteristics Other: At least 4 weeks since prior use of medical device No concurrent investigational agents

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Comprehensive Cancer Center
state: Alabama
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital - Atlanta
state: Georgia
city: Baltimore
country: United States
facility: Johns Hopkins Oncology Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania Cancer Center
state: Pennsylvania
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: Wake Forest University Health Sciences
name: Stephen Tatter, MD, PhD
role: STUDY_CHAIR
References: