Know Cancer

forgot password

Phase I Study of At-Labeled Anti-Tenascin Human/Mouse Chimeric Monoclonal Antibody 81C6 (ch81C6) Via Surgically Created Cystic Resection Cavity in the Treatment of Patients With Primary or Metastatic Brain Tumors

Phase 1/Phase 2
18 Years
Not Enrolling
Brain and Central Nervous System Tumors, Metastatic Cancer, Neuroblastoma

Thank you

Trial Information

Phase I Study of At-Labeled Anti-Tenascin Human/Mouse Chimeric Monoclonal Antibody 81C6 (ch81C6) Via Surgically Created Cystic Resection Cavity in the Treatment of Patients With Primary or Metastatic Brain Tumors


- Determine the toxicity of monoclonal antibody (MAb) Astatine At 211 Antitenascin
Human/Mouse Chimeric 81C6 (At 211 MAb 81C6) therapy delivered via the intracranial
resection cavity in patients with recurrent primary or metastatic malignant brain

- Identify objective therapeutic responses of these patients to this treatment.

OUTLINE: This is a dose escalation study.

Patients undergo surgical resection of their tumor at which time an indwelling intracranial
resection cavity catheter is surgically placed. Patients receive one dose of astatine At 211
antitenascin monoclonal antibody 81C6 (At 211 MAb 81C6) via the intralesional catheter.

Cohorts of 3-6 patients are treated at escalating doses of At 211 MAb 81C6. The maximum
tolerated dose is the highest dose at which no more than 3 of 6 patients experience dose
limiting toxicity.

Patients are followed initially at 4 weeks, then at approximately 12 weeks, at 24 weeks, and
then every 12 weeks for 1 year.

PROJECTED ACCRUAL: A total of 12-24 patients will be accrued for this study within 18-24

Inclusion Criteria


- Histologically confirmed newly diagnosed or recurrent supratentorial primary or
metastatic malignant brain tumor

- Measurable disease by MRI or CT scan

- Candidate for surgical resection

- Extension of tumor no more than 1.0 cm beyond the margin of the surgical cavity

- Demonstrated reactivity of tumor cells with tenascin by immunohistology with either a
polyclonal rabbit antibody or the monoclonal mouse antibody

- No infratentorial tumors, diffusely infiltrating tumors, tumors with subependymal
spread, or multifocal tumors



- 18 and over

Performance status:

- Karnofsky 50-100%

Life expectancy:

- Not specified


- Absolute neutrophil count greater than 1000/mm^3

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


- Bilirubin less than 1.5 mg/dL

- Alkaline phosphatase less than 1.5 times normal

- SGOT less than 1.5 times normal


- Creatinine less than 1.2 mg/dL


- Not pregnant or nursing

- Fertile patients must use effective contraception


Biologic therapy:

- Not specified


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

Endocrine therapy:

- Concurrent corticosteroids allowed, but must be on stable dose for at least 1 week


- At least 3 months since prior radiotherapy to site of measurable disease in the CNS


- See Disease Characteristics

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Darell D. Bigner, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke Cancer Institute


United States: Federal Government

Study ID:

2237 (CDR0000066493)



Start Date:

February 1998

Completion Date:

February 2005

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Metastatic Cancer
  • Neuroblastoma
  • localized resectable neuroblastoma
  • recurrent neuroblastoma
  • recurrent adult brain tumor
  • adult craniopharyngioma
  • adult medulloblastoma
  • adult meningioma
  • adult glioblastoma
  • adult oligodendroglioma
  • tumors metastatic to brain
  • adult anaplastic astrocytoma
  • adult mixed glioma
  • adult pineal parenchymal tumor
  • adult central nervous system germ cell tumor
  • adult grade III meningioma
  • adult pilocytic astrocytoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • adult pineal gland astrocytoma
  • Brain Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Nervous System Neoplasms
  • Neuroblastoma
  • Central Nervous System Neoplasms



Duke Comprehensive Cancer Center Durham, North Carolina  27710