Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Cancers

Duke University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Metastatic Cancer; Brain and Central Nervous System Tumors

Treatments: Radiation: iodine I 131 monoclonal antibody 81C6

Study type: Interventional

Funder types: Other

Identifiers

NCT00002752

DUMC-307-98-2R5

CDR0000064688 (Other Identifier)

DUMC-2426-01-2R8 (Other Identifier)

DUMC-307-97-2R4

DUMC-000223-00-2R7 (Other Identifier)

Pro00004635

DUMC-0328-99-2R6 (Other Identifier)

NCI-H96-0009

DUMC-221-96-2R3 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 3+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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