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PHASE I STUDY OF ANTI-TENASCIN MONOCLONAL ANTIBODY 131I 81C6 VIA SURGICALLY CREATED CYSTIC RESECTION CAVITY IN THE TREATMENT OF PATIENTS WITH PRIMARY OR METASTATIC MALIGNANT BRAIN TUMORS


Phase 1/Phase 2
3 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors, Metastatic Cancer

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Trial Information

PHASE I STUDY OF ANTI-TENASCIN MONOCLONAL ANTIBODY 131I 81C6 VIA SURGICALLY CREATED CYSTIC RESECTION CAVITY IN THE TREATMENT OF PATIENTS WITH PRIMARY OR METASTATIC MALIGNANT BRAIN TUMORS


OBJECTIVES:

- Determine the toxic effects of intracranial iodine I 131 labeled anti-tenascin
monoclonal antibody 81C6 in patients with primary or metastatic anaplastic gliomas.

- Determine the objective therapeutic response of these patients treated with this
regimen.

OUTLINE: This is a dose escalation study of iodine I 131 labeled anti-tenascin monoclonal
antibody 81C6 (MOAB 81C6). Patients are stratified by prior external beam radiotherapy (yes
vs no).

Patients receive iodine I 131 labeled MOAB 81C6 intraventricularly followed by unlabeled
MOAB 81C6 intraventricularly.

Cohorts of 3-6 patients receive escalating doses of iodine I 131 labeled MOAB 81C6 until the
maximum tolerated dose is determined. The MTD is defined as the highest dose preceding that
at which 3 of 6 patients experience dose-limiting toxicity.

Patients are followed monthly for 2 years, every 2 months for 2 years, and then every 3
months thereafter.

PROJECTED ACCRUAL: A total of 3-6 patients per cohort will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven primary or metastatic malignant supratentorial anaplastic
glioma

- Newly diagnosed or recurrent

- No diffusely infiltrating or multifocal tumor

- No tumor with subependymal spread

- Resection of glioma and placement of an intralesional catheter into the surgical
cavity required before study

- Measurable lesion on enhanced CT scan or MRI

- No measurable enhancing lesion greater than 1.0 cm beyond cavity margin

- Neoplastic cell reactivity with tenascin demonstrated by immunohistology with either
a polyclonal rabbit antibody or a monoclonal murine antibody

PATIENT CHARACTERISTICS:

Age:

- 3 and over

Performance status:

- Karnofsky 50-100%

Hematopoietic:

- Absolute neutrophil count greater than 1,000/mm^3

- Platelet count greater than 100,000/mm^3

Hepatic:

- Bilirubin less than 1.5 mg/dL

- AST less than 1.5 times normal

- Alkaline phosphatase less than 1.5 times normal

Renal:

- Creatinine less than 1.2 mg/dL

Other:

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- At least 6 weeks since prior chemotherapy unless unequivocal evidence of tumor
progression

Endocrine therapy:

- Corticosteroids allowed if at lowest possible dose and dose stable for at least 10
days prior to entry

Radiotherapy:

- At least 3 months since prior radiotherapy to site of measurable disease unless
unequivocal evidence of tumor progression

Surgery:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Darell D. Bigner, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke Cancer Institute

Authority:

United States: Federal Government

Study ID:

Pro00004635

NCT ID:

NCT00002752

Start Date:

February 1993

Completion Date:

March 2010

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Metastatic Cancer
  • childhood supratentorial ependymoma
  • recurrent childhood brain tumor
  • recurrent adult brain tumor
  • adult medulloblastoma
  • adult glioblastoma
  • tumors metastatic to brain
  • childhood high-grade cerebral astrocytoma
  • adult anaplastic astrocytoma
  • adult myxopapillary ependymoma
  • adult anaplastic ependymoma
  • adult anaplastic oligodendroglioma
  • adult mixed glioma
  • adult pilocytic astrocytoma
  • adult subependymoma
  • adult ependymoblastoma
  • recurrent childhood supratentorial primitive neuroectodermal tumor
  • recurrent childhood cerebellar astrocytoma
  • recurrent childhood cerebral astrocytoma
  • recurrent childhood medulloblastoma
  • newly diagnosed childhood ependymoma
  • recurrent childhood ependymoma
  • adult oligodendroglioma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Brain Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Duke Comprehensive Cancer CenterDurham, North Carolina  27710