An inflatable balloon catheter and liquid 125I radiation source (GliaSite Radiation Therapy System) for treatment of recurrent malignant glioma: multicenter safety and feasibility trial

View More View Less
  • 1 Departments of Neurosurgery and Radiation Oncology, Wake Forest University, Winston—Salem, North Carolina; Departments of Neurosurgery and Radiation, Henry Ford Hospital, Detroit, Michigan; Departments of Neurosurgery, Radiation Oncology, Oncology, and Biostatistics, The Johns Hopkins University, Baltimore, Maryland; Departments of Neurosurgery and Radiation Oncology, Emory University, Atlanta, Georgia; Departments of Neurosurgery and Radiation Oncology, Moffitt Cancer Center, Tampa, Florida; and The New Approaches to Brain Tumor Therapy Central Nervous System Consortium
Restricted access

Purchase Now

USD  $45.00

JNS + Pediatrics - 1 year subscription bundle (Individuals Only)

USD  $515.00

JNS + Pediatrics + Spine - 1 year subscription bundle (Individuals Only)

USD  $612.00
Print or Print + Online

Object. In this study the authors evaluated the safety and performance of the GliaSite Radiation Therapy System (RTS) in patients with recurrent malignant brain tumors who were undergoing tumor resection.

Methods. The GliaSite is an inflatable balloon catheter that is placed in the resection cavity at the time of tumor debulking. Low-dose-rate radiation is delivered with an aqueous solution of organically bound iodine-125 (Iotrex [sodium 3-(125I)-iodo-4-hydroxybenzenesulfonate]), which are temporarily introduced into the balloon portion of the device via a subcutaneous port. Adults with recurrent malignant glioma underwent resection and GliaSite implantation. One to 2 weeks later, the device was filled with Iotrex for 3 to 6 days, following which the device was explanted. Twenty-one patients with recurrent high-grade astrocytomas were enrolled in the study and received radiation therapy. There were two end points: 1) successful implantation and delivery of brachytherapy; and 2) safety of the device.

Implantation of the device, delivery of radiation, and the explantation procedure were well tolerated. At least 40 to 60 Gy was delivered to all tissues within the target volume. There were no serious adverse device-related events during brachytherapy. One patient had a pseudomeningocele, one patient had a wound infection, and three patients had meningitis (one bacterial, one chemical, and one aseptic). No symptomatic radiation necrosis was identified during 21.8 patient-years of follow up. The median survival of previously treated patients was 12.7 months (95% confidence interval 6.9–15.3 months).

Conclusions. The GliaSite RTS performs safely and efficiently. It delivers a readily quantifiable dose of radiation to tissue at the highest risk for tumor recurrence.

JNS + Pediatrics - 1 year subscription bundle (Individuals Only)

USD  $515.00

JNS + Pediatrics + Spine - 1 year subscription bundle (Individuals Only)

USD  $612.00
  • 1.

    Akabani G, , Reist CJ, & Cokgor I, et al: Dosimetry of 131I-labeled 81C6 monoclonal antibody administered into surgically created resection cavities in patients with malignant brain tumors. J Nucl Med 40:631638, 1999 Akabani G, Reist CJ, Cokgor I, et al: Dosimetry of 131I-labeled 81C6 monoclonal antibody administered into surgically created resection cavities in patients with malignant brain tumors. J Nucl Med 40:631–638, 1999

    • Search Google Scholar
    • Export Citation
  • 2.

    Bernstein M, , Laperriere N, & Glen J, et al: Brachytherapy for recurrent malignant astrocytoma. Int J Radiat Oncol Biol Phys 30:12131217, 1994 Bernstein M, Laperriere N, Glen J, et al: Brachytherapy for recurrent malignant astrocytoma. Int J Radiat Oncol Biol Phys 30:1213–1217, 1994

    • Search Google Scholar
    • Export Citation
  • 3.

    Cokgor I, , Akabani G, & Kuan CT, et al: Phase I trial results of iodine-131-labeled antitenascin monoclonal antibody 81C6 treatment of patients with newly diagnosed malignant gliomas. J Clin Oncol 18:38623872, 2000 Cokgor I, Akabani G, Kuan CT, et al: Phase I trial results of iodine-131-labeled antitenascin monoclonal antibody 81C6 treatment of patients with newly diagnosed malignant gliomas. J Clin Oncol 18:3862–3872, 2000

    • Search Google Scholar
    • Export Citation
  • 4.

    Dempsey JF, , Williams JA, & Stubbs JB, et al: Dosimetric properties of a novel brachytherapy balloon applicator for the treatment of malignant brain-tumor resection-cavity margins. Int J Radiat Oncol Biol Phys 42:421429, 1998 Dempsey JF, Williams JA, Stubbs JB, et al: Dosimetric properties of a novel brachytherapy balloon applicator for the treatment of malignant brain-tumor resection-cavity margins. Int J Radiat Oncol Biol Phys 42:421–429, 1998

    • Search Google Scholar
    • Export Citation
  • 5.

    Johannesen TB, , Watne K, & Lote K, et al: Intracavity fractionated balloon brachytherapy in glioblastoma. Acta Neurochir 141:127133, 1999 Johannesen TB, Watne K, Lote K, et al: Intracavity fractionated balloon brachytherapy in glioblastoma. Acta Neurochir 141:127–133, 1999

    • Search Google Scholar
    • Export Citation
  • 6.

    Kaplan EL, & Meier P: Nonparametric estimation from incomplete observations. J Am Stat Assoc 53:457481, 1958 Kaplan EL, Meier P: Nonparametric estimation from incomplete observations. J Am Stat Assoc 53:457–481, 1958

    • Search Google Scholar
    • Export Citation
  • 7.

    Laperriere NJ, , Leung PM, & McKenzie S, et al: Randomized study of brachytherapy in the initial management of patients with malignant astrocytoma. Int J Radiat Oncol Biol Phys 41:10051011, 1998 Laperriere NJ, Leung PM, McKenzie S, et al: Randomized study of brachytherapy in the initial management of patients with malignant astrocytoma. Int J Radiat Oncol Biol Phys 41:1005–1011, 1998

    • Search Google Scholar
    • Export Citation
  • 8.

    Lee SW, , Fraass BA, & Marsh LH, et al: Patterns of failure following high-dose 3-D conformal radiotherapy for high-grade astrocytomas: a quantitative dosimetric study. Int J Radiat Oncol Biol Phys 43:7988, 1999 Lee SW, Fraass BA, Marsh LH, et al: Patterns of failure following high-dose 3-D conformal radiotherapy for high-grade astrocytomas: a quantitative dosimetric study. Int J Radiat Oncol Biol Phys 43:79–88, 1999

    • Search Google Scholar
    • Export Citation
  • 9.

    Leibel SA, , Gutin PH, & Davis RL: Factors affecting radiation injury after interstitial brachytherapy for brain tumors, in Gutin PH, , Leibel SA, & Sheline GE (eds): Radiation Injury to the Nervous System. New York: Raven Press, 1991, pp 257270 Leibel SA, Gutin PH, Davis RL: Factors affecting radiation injury after interstitial brachytherapy for brain tumors, in Gutin PH, Leibel SA, Sheline GE (eds): Radiation Injury to the Nervous System. New York: Raven Press, 1991, pp 257–270

    • Search Google Scholar
    • Export Citation
  • 10.

    Ling CC, , Anderson LL, & Shipley WU: Dose inhomogeneity in interstitial implants using 125I seeds. Int J Radiat Oncol Biol Phys 5: 419425, 1979 Ling CC, Anderson LL, Shipley WU: Dose inhomogeneity in interstitial implants using 125I seeds. Int J Radiat Oncol Biol Phys 5:419–425, 1979

    • Search Google Scholar
    • Export Citation
  • 11.

    McDermott MW, , Gutin PH, & Larson DA, et al: Interstitial brachytherapy. Neurosurg Clin N Am 1:801824, 1990 McDermott MW, Gutin PH, Larson DA, et al: Interstitial brachytherapy. Neurosurg Clin N Am 1:801–824, 1990

    • Search Google Scholar
    • Export Citation
  • 12.

    Monroe JI, , Dempsey JF, & Dorton JA, et al: Experimental validation of dose calculation algorithms for the GliaSite RTS, a novel 125I liquid-filled balloon brachytherapy applicator. Med Phys 28:7385, 2001 Monroe JI, Dempsey JF, Dorton JA, et al: Experimental validation of dose calculation algorithms for the GliaSite RTS, a novel 125I liquid-filled balloon brachytherapy applicator. Med Phys 28:73–85, 2001

    • Search Google Scholar
    • Export Citation
  • 13.

    Prados MD, , Gutin PH, & Phillips TL, et al: Interstitial brachytherapy for newly diagnosed patients with malignant gliomas: the UCSF experience. Int J Radiat Oncol Biol Phys 24:593597, 1992 Prados MD, Gutin PH, Phillips TL, et al: Interstitial brachytherapy for newly diagnosed patients with malignant gliomas: the UCSF experience. Int J Radiat Oncol Biol Phys 24:593–597, 1992

    • Search Google Scholar
    • Export Citation
  • 14.

    Prasad SC, , Bassano DA, & Fear PI, et al: Dosimetry of I-125 seeds implanted on the surface of a cavity. Med Dosim 15:217219, 1990 Prasad SC, Bassano DA, Fear PI, et al: Dosimetry of I-125 seeds implanted on the surface of a cavity. Med Dosim 15:217–219, 1990

    • Search Google Scholar
    • Export Citation
  • 15.

    Reardon DA, , Akabani G, & Coleman RE, et al: Phase II trial of murine 131I-labeled antitenascin monoclonal antibody 81C6 administered into surgically created resection cavities of patients with newly diagnosed malignant gliomas. J Clin Oncol 20:13891397, 2002 Reardon DA, Akabani G, Coleman RE, et al: Phase II trial of murine 131I-labeled antitenascin monoclonal antibody 81C6 administered into surgically created resection cavities of patients with newly diagnosed malignant gliomas. J Clin Oncol 20:1389–1397, 2002

    • Search Google Scholar
    • Export Citation
  • 16.

    Saw CB, , Suntharalingam N, & Ayyangar KM, et al: Dosimetric considerations of stereotactic brain implants. Int J Radiat Oncol Biol Phys 17:887891, 1989 Saw CB, Suntharalingam N, Ayyangar KM, et al: Dosimetric considerations of stereotactic brain implants. Int J Radiat Oncol Biol Phys 17:887–891, 1989

    • Search Google Scholar
    • Export Citation
  • 17.

    Scharfen CO, , Sneed PK, & Wara WM, et al: High activity iodine-125 interstitial implant for gliomas. Int J Radiat Oncol Biol Phys 24:583591, 1992 Scharfen CO, Sneed PK, Wara WM, et al: High activity iodine-125 interstitial implant for gliomas. Int J Radiat Oncol Biol Phys 24:583–591, 1992

    • Search Google Scholar
    • Export Citation
  • 18.

    Sneed PK, , Gutin PH, & Larson DA, et al: Patterns of recurrence of glioblastoma multiforme after external irradiation followed by implant boost. Int J Radiat Oncol Biol Phys 29:719727, 1994 Sneed PK, Gutin PH, Larson DA, et al: Patterns of recurrence of glioblastoma multiforme after external irradiation followed by implant boost. Int J Radiat Oncol Biol Phys 29:719–727, 1994

    • Search Google Scholar
    • Export Citation
  • 19.

    Sneed PK, , Lamborn KR, & Larson DA, et al: Demonstration of brachytherapy boost dose-response relationships in glioblastoma multiforme. Int J Radiat Oncol Biol Phys 35:3744, 1996 Sneed PK, Lamborn KR, Larson DA, et al: Demonstration of brachytherapy boost dose-response relationships in glioblastoma multiforme. Int J Radiat Oncol Biol Phys 35:37–44, 1996

    • Search Google Scholar
    • Export Citation
  • 20.

    Sneed PK, , McDermott MW, & Gutin PH: Interstitial brachytherapy procedures for brain tumors. Semin Surg Oncol 13:157166, 1997 Sneed PK, McDermott MW, Gutin PH: Interstitial brachytherapy procedures for brain tumors. Semin Surg Oncol 13:157–166, 1997

    • Search Google Scholar
    • Export Citation
  • 21.

    Stubbs JB, , Frankel RH, & Schultz K, et al: Preclinical evaluation of a novel device for delivering brachytherapy to the margins of resected brain tumor cavities. J Neurosurg 96:335343, 2002 Stubbs JB, Frankel RH, Schultz K, et al: Preclinical evaluation of a novel device for delivering brachytherapy to the margins of resected brain tumor cavities. J Neurosurg 96:335–343, 2002

    • Search Google Scholar
    • Export Citation
  • 22.

    Stubbs JB, , Strickland AD, & Frank RK, et al: Biodistribution and dosimetry of an aqueous solution containing sodium 3-(125I)iodo-4-hydroxybenzenesulfonate (Iotrex) for brachytherapy of resected malignant brain tumors. Cancer Biother Radiopharm 15:645656, 2000 Stubbs JB, Strickland AD, Frank RK, et al: Biodistribution and dosimetry of an aqueous solution containing sodium 3-(125I)iodo-4-hydroxybenzenesulfonate (Iotrex) for brachytherapy of resected malignant brain tumors. Cancer Biother Radiopharm 15:645–656, 2000

    • Search Google Scholar
    • Export Citation
  • 23.

    Videtic GM, , Gaspar LE, & Zamorano L, et al: Use of the RTOG recursive partitioning analysis to validate the benefit of iodine-125 implants in the primary treatment of malignant gliomas. Int J Radiat Oncol Biol Phys 45:687692, 1999 Videtic GM, Gaspar LE, Zamorano L, et al: Use of the RTOG recursive partitioning analysis to validate the benefit of iodine-125 implants in the primary treatment of malignant gliomas. Int J Radiat Oncol Biol Phys 45:687–692, 1999

    • Search Google Scholar
    • Export Citation
  • 24.

    Wallner KE, , Galicich JH, & Krol G, et al: Patterns of failure following treatment for glioblastoma multiforme and anaplastic astrocytoma. Int J Radiat Oncol Biol Phys 16:14051409, 1989 Wallner KE, Galicich JH, Krol G, et al: Patterns of failure following treatment for glioblastoma multiforme and anaplastic astrocytoma. Int J Radiat Oncol Biol Phys 16:1405–1409, 1989

    • Search Google Scholar
    • Export Citation
  • 25.

    Wen PY, , Alexander E III, & Black PM, et al: Long term results of stereotactic brachytherapy used in the initial treatment of patients with glioblastomas. Cancer 73:30293036, 1994 Wen PY, Alexander E III, Black PM, et al: Long term results of stereotactic brachytherapy used in the initial treatment of patients with glioblastomas. Cancer 73:3029–3036, 1994

    • Search Google Scholar
    • Export Citation

Metrics

All Time Past Year Past 30 Days
Abstract Views 693 185 20
Full Text Views 230 15 3
PDF Downloads 125 8 2
EPUB Downloads 0 0 0