Clinical trial NCT00002752: Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Cancers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Brain and Central Nervous System Tumors
Metastatic Cancer
Keywords: 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
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2003-07-08
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients who have primary or metastatic brain cancer.

Detailed description: 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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Duke Cancer Institute
name: Darell D. Bigner, MD, PhD
role: STUDY_CHAIR
References: