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PROTOCOL FOR A PHASE I STUDY OF INTRACYSTIC ANTI-TENASCIN MONOCLONAL ANTIBODY 131I 81C6 IN THE TREATMENT OF PATIENTS WITH RECURRENT CYSTIC GLIOMAS


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

Thank you

Trial Information

PROTOCOL FOR A PHASE I STUDY OF INTRACYSTIC ANTI-TENASCIN MONOCLONAL ANTIBODY 131I 81C6 IN THE TREATMENT OF PATIENTS WITH RECURRENT CYSTIC GLIOMAS


OBJECTIVES: I. Assess the toxic effects of intracystic administration of iodine-131-labeled
anti-tenascin monoclonal antibody 81C6. II. Identify any objective therapeutic responses to
this treatment in patients with recurrent cystic anaplastic gliomas.

OUTLINE: Radioimmunotherapy. Iodine-131-Labeled Anti-Tenascin Monoclonal Antibody 81C6,
131I-81C6.

PROJECTED ACCRUAL: Three to six patients will be entered at each dose studied.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed supratentorial anaplastic glioma with a
recurrent cyst requiring aspiration for symptom control Measurable cystic lesion confirmed
by contrast-enhanced CT or MRI At least 3 months since radiotherapy to site of measurable
disease unless unequivocal evidence of tumor progression 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/mm3 Platelet count greater
than 100,000/mm3 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: Negative pregnancy test Effective contraception required of fertile women

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 weeks
since antineoplastic 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: See Disease Characteristics Surgery: Not
specified

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:

CDR0000064689

NCT ID:

NCT00002753

Start Date:

November 1991

Completion Date:

April 2001

Related Keywords:

  • Brain and Central Nervous System Tumors
  • childhood supratentorial ependymoma
  • recurrent childhood brain tumor
  • recurrent adult brain tumor
  • adult glioblastoma
  • adult anaplastic astrocytoma
  • adult myxopapillary ependymoma
  • adult anaplastic ependymoma
  • adult anaplastic oligodendroglioma
  • adult mixed glioma
  • adult ependymoblastoma
  • recurrent childhood cerebral astrocytoma
  • recurrent childhood ependymoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Duke Comprehensive Cancer CenterDurham, North Carolina  27710