BNCT to Treat Glioma That Has Progressed Following Radiotherapy

NCT00115440 | Completed Phase 1

• 2 other identifiers: FIN-BNCT-03/2000BNCT P-03
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Boron Neutron Capture Therapy (BNCT) is an experimental radiation therapy technique which is based on the principle of irradiating boron atoms with neutrons. When neutrons have relatively low energy, boron atoms that have been targeted to cancerous tissue using a suitable boron carrier (an amino acid derivative called BPA, boronophenylalanine) will capture the neutrons. As a result from the neutron capture the boron atoms will split into two, producing helium and lithium ions. The helium and lithium ions, in turn, have only a short pathlength in tissue (about 5 micrometers) and will deposit their cell damaging effect mainly within the tumor provided that the boron carrier (BPA) has accumulated in the tumor. In practice, the study participants will receive BPA as an approximately 2-hour intravenous infusion, following which the tumor is irradiated with low energy (epithermal) neutrons obtained from a nuclear reactor at the BNCT facility. BNCT requires careful radiation dose planning, but neutron irradiation will last approximately only for one hour. In this study BNCT is given once. The study hypothesis is that anaplastic astrocytomas and glioblastomas that have recurred following conventional radiotherapy might accumulate the boron carrier compound, and might respond to BNCT.

Conditions

Glioblastoma; Anaplastic Astrocytoma

Keywords

glioblastoma; anaplastic astrocytoma; boron neutron capture therapy; radiation therapy; boronophenylalanine

Outcome Measures

Primary Outcomes (1)

• safety

  3 years

Secondary Outcomes (3)

• survival

  3 years

• adverse effects of BNCT

  3 years

• quality-of-life

  3 years

Study Arms (1)

A

EXPERIMENTAL

Active treatment arm.

Radiation: Bononophenylalanine (BPA)-based BNCT

Interventions

Bononophenylalanine (BPA)-based BNCT RADIATION

Boronophenylalanine is infused into a peripheral vein prior to neutron irradiation.

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed supratentorial glioblastoma or anaplastic astrocytoma.
• Recurred tumor after surgery and radiotherapy or tumor progressing after radiotherapy.
• Recurrence/progression has been confirmed by serial MRI scans and a biopsy, or by debulking surgery.
• The World Health Organization performance status \<2.
• WBC \>2,500/mm3, platelet count \>75,000/mm3, serum creatinine \<180 umol/L.
• A written informed consent

You may not qualify if:

• Age less than 18
• Tumor infiltrates into the brain stem or the optic tracts
• The majority of tumor tissue consists of grade II glioma with only a focal grade III component
• A minimum gross tumor dose of 17 Gy (W) is not obtained in dose-planning
• Less than 6 months has elapsed from the last date of external irradiation
• Less than 4 weeks has elapsed from the last cancer chemotherapy dose prior to giving BNCT
• The total conventional radiation therapy dose given is more than 61 Gy or less than 50 Gy, or one of nonconventional fractionation schemes has been used (conventional: 1.8-2.0 Gy/day, 5 days per week, weekly dose 9 to 10 Gy)
• More than approximately 1/3 of the total brain volume has been within the 90% isodose
• Gliomas where the enhancing tumor volume is larger than 2/3 of the volume of one hemisphere in the MRI examination preceding BNCT
• More than one radiotherapy course has been given to the brain tumor
• Untreated congestive heart failure or renal failure
• Uncontrolled brain oedema despite the use of corticosteroids
• A cardiac pace-maker or an unremovable metal implant present in the head and neck region that will interfere with MRI-based dose-planning
• Restlessness or inability to lie in a cast for 30 to 60 minutes
• Clinical follow-up after therapy cannot be arranged

Sponsors & Collaborators

• Boneca Corporation: lead

Study Sites (1)

Department of Oncology, Helsinki University Central Hospital

Helsinki, FIN-00029, Finland

Location

Related Publications (2)

• Kouri M, Kankaanranta L, Seppala T, Tervo L, Rasilainen M, Minn H, Eskola O, Vahatalo J, Paetau A, Savolainen S, Auterinen I, Jaaskelainen J, Joensuu H. Undifferentiated sinonasal carcinoma may respond to single-fraction boron neutron capture therapy. Radiother Oncol. 2004 Jul;72(1):83-5. doi: 10.1016/j.radonc.2004.03.016.

  PMID: 15236879 BACKGROUND

• Joensuu H, Kankaanranta L, Seppala T, Auterinen I, Kallio M, Kulvik M, Laakso J, Vahatalo J, Kortesniemi M, Kotiluoto P, Seren T, Karila J, Brander A, Jarviluoma E, Ryynanen P, Paetau A, Ruokonen I, Minn H, Tenhunen M, Jaaskelainen J, Farkkila M, Savolainen S. Boron neutron capture therapy of brain tumors: clinical trials at the finnish facility using boronophenylalanine. J Neurooncol. 2003 Mar-Apr;62(1-2):123-34. doi: 10.1007/BF02699939.

  PMID: 12749708 RESULT

MeSH Terms

Conditions

Glioblastoma; Astrocytoma

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Heikki T Joensuu, M.D., prof.

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 22, 2005
• First Posted: June 23, 2005
• Study Start: March 1, 2001
• Primary Completion: December 1, 2008
• Study Completion: January 1, 2009
• Last Updated: January 28, 2009

Record last verified: 2007-09

Locations

FI (1)