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Phase I/II Study of Intracystic Administration of 131I-Labeled Anti-Tenascin Monoclonal Antibody 81C6 for Patients With Recurrent Cystic Gliomas (Summary Last Modified 07/2000)

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Monoclonal Antibody Therapy in Treating Patients With Recurrent Gliomas

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase II, Phase I

Treatment

Closed

3 and over

DUMC-1965-98-12R7
DUMC-1752-96-12R5, DUMC-1775-95-12R4, DUMC-1860-97-12R6, NCI-H96-0008, NCT00002753

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.

Entry 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

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

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

Expected Enrollment

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

Outline

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

Trial Contact Information

Trial Lead Organizations

Duke Comprehensive Cancer Center

Darell Bigner, MD, PhD, Protocol chair(Contact information may not be current)
Ph: 919-684-5018
Email: bigne001@mc.duke.edu

Registry Information

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

Trial Start Date		1991-11-14

Registered in ClinicalTrials.gov		NCT00002753

Date Submitted to PDQ		1991-11-14

Information Last Verified		2000-07-01

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.