Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Stephen Tatter, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Federal Government

Study ID:

CDR0000066641

NCT ID:

NCT00003574

Start Date:

April 1999

Completion Date:

June 2004

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult glioblastoma
  • adult anaplastic astrocytoma
  • adult anaplastic oligodendroglioma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Brain Neoplasms
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

University of Alabama Comprehensive Cancer CenterBirmingham, Alabama  35294
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Emory University Hospital - AtlantaAtlanta, Georgia  30322
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Henry Ford HospitalDetroit, Michigan  48202