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A Phase I/II Trial For Neutron Capture Therapy In Glioblastoma Multiforme And Intracranial Melanoma


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors, Melanoma (Skin), Metastatic Cancer

Thank you

Trial Information

A Phase I/II Trial For Neutron Capture Therapy In Glioblastoma Multiforme And Intracranial Melanoma


OBJECTIVES:

- Determine the time course, uniformity, and severity of acute and chronic normal tissue
reactions in patients with glioblastoma multiforme or intracranial melanoma treated
with boronophenylalanine-fructose complex (BPA-f) followed by cranial neutron
irradiation using a new fission converter beam facility.

- Determine the maximum tolerated dose of cranial neutron capture therapy in these
patients.

- Determine, through serial objective measurements, the clinical response in patients
treated with this therapy.

- Determine the pharmacokinetics of BPA-f in these patients.

OUTLINE: This is a dose-escalation study of cranial neutron capture therapy (NCT).

Patients receive boronophenylalanine-fructose complex IV over 90 minutes followed by cranial
NCT on days 1 and 2.

Cohorts of 3-6 patients receive escalating doses of NCT until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6
patients experience dose-limiting toxicity. Once the MTD is determined, additional patients
are treated at the MTD.

Patients are followed at 1, 2, 4, 6, 9, and 12 months and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 16 patients will be accrued for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed glioblastoma multiforme OR

- Radiographically diagnosed brain metastases after a diagnosis of melanoma

- Contrast-enhanced tumor volume must not exceed 60 mL

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- At least 6 months

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Creatinine normal

Cardiovascular:

- No prior severe cardiac disease, including the following:

- Uncontrolled arrhythmias or conduction defects

- Unstable or newly diagnosed angina pectoris

- Recent coronary artery disease

- Congestive heart failure

Other:

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception during and for at least 6 months
after study

- No prior phenylketonuria

- No cognitive impairment that would preclude informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No concurrent chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior cranial irradiation

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Paul M. Busse, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Beth Israel Deaconess Medical Center

Authority:

United States: Federal Government

Study ID:

BIDMC-E-010284FB

NCT ID:

NCT00039572

Start Date:

May 2002

Completion Date:

January 2005

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Melanoma (Skin)
  • Metastatic Cancer
  • adult glioblastoma
  • stage IV melanoma
  • tumors metastatic to brain
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Glioblastoma
  • Melanoma
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Massachusetts Institute of Technology Cambridge, Massachusetts  02139