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

Alternate Title

Interferon beta in Treating Patients With Recurrent Gliomas or Astrocytomas

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 18 and over NCI MDA-NCNSC-96314 NCI-T94-0125, T94-0125

Objectives

I. Determine the antitumor activity of interferon beta-1a for recurrent high 
grade gliomas and/or astrocytomas.

II. Obtain additional data on the toxic effects of interferon beta-1a in these 
patients.

Entry Criteria

Disease Characteristics:

CT or MRI proven recurrent high grade mixed gliomas or astrocytomas
Histologically proven tumor type

Prior/Concurrent Therapy:

Biologic therapy:
 No more than two biologic therapy regimens prior to study

Chemotherapy:
 No more than two chemotherapy regimens prior to study
 No prior chemotherapy within 3 weeks of study
 No prior nitrosoureas and mitomycin within 6 weeks of study

Endocrine therapy:
 Not specified

Radiotherapy:
 External beam radiation required prior to study
 No prior radiation therapy within 3 weeks of study
 Patients with prior treatment of high dose focal radiotherapy should have a   
   confirmatory metabolic imaging test
 
Surgery:
 Not specified
 

Patient Characteristics:

Age:
 18 and over

Performance Status:
 Karnofsky greater than 60

Life Expectancy:
 Greater than 2 months

Hematopoietic:
 WBC greater than 3000/mm3
 Platelet count greater than 100,000/mm3
 
Hepatic:
 Bilirubin less than 1.5 times mg/dL
 SGOT less than 3.0 times upper limit of normal 
 No active hepatic disease

Renal:
 Creatinine less than 1.5 mg/dL
 No active renal disease

Cardiovascular:
 No active cardiac disease
 
Other:
 No psychosis

Expected Enrollment

A maximum of 35 patients will be enrolled.  Accrual should be completed in 
approximately 6 months.

Outline

Patients are treated three times per week with intramuscular injections of 
interferon beta-1a. Treatment takes place on a Monday, Wednesday, and Friday 
schedule. Acetaminophen is taken every four hours, beginning one hour prior to 
each interferon beta-1a injection and continuing for a 24 hour period.  

Patients are treated for six weeks followed by a one week resting period. 
During this resting period patients undergo evaluation for tumor restaging.
If tumor response or stable disease is observed, treatment will continue for 
another six week cycle.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Wai-Kwan Yung, MD, Protocol chair		Ph: 713-794-1285; 800-392-1611