Clinical Trials (PDQ®) - National Cancer Institute

Page Options

	Quick Links


	Director's Corner Dictionary of Cancer Terms NCI Drug Dictionary Funding Opportunities NCI Publications Advisory Boards and Groups Science Serving People Español

Questions about cancer?


	1-800-4-CANCER

	LiveHelp® online chat

	NCI Highlights


	Virtual and Standard Colonoscopy Both Accurate Denosumab May Help Prevent Bone Loss Past Highlights

Phase III Randomized, Placebo-Controlled Study of CCNU with vs without Benznidazole in Patients with Malignant Glioma

Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase III

Treatment

Closed

under 75

MRC-BR03
EU-94010

Objectives

I.  Evaluate the response rate, survival, and toxicities produced by lomustine 
given with and without benznidazole in patients with malignant glioma.

Entry Criteria

Disease Characteristics:


Pathologically proven Grade 3/4 glioma with CT documentation of
recurrence
  Recurrent disease following treatment on protocols MRC-MIS-B
  or MRC-BR2 is eligible

  Patients considered at diagnosis unsuitable for postoperative
  radiotherapy may be eligible

Neurologic status better than 4 (MRC scale)

Prior/Concurrent Therapy:


Stable recovery from neurosurgery required

More than 4 weeks since prior radiotherapy

Patient Characteristics:


Age:
  Under 75

Performance status:
  WHO 0-3

Life expectancy:
  At least 45 days

Hematopoietic:
  WBC greater than 3,500
  Platelets greater than 150,000

Hepatic:
  Bilirubin normal
  SGOT/SGPT normal

Renal:
  BUN less than 28 mg/dl (10 micromoles/liter) OR
  Creatinine less than 1.3 mg/dl (120 micromoles/liter) or
     creatinine clearance normal

Expected Enrollment

At least 25 patients will be treated on each arm.  Accrual is expected to be 
completed in 2 years.

Outline

Randomized, double-blind study.

Arm I:  Single-Agent Chemotherapy with Chemosensitization.  Lomustine, CCNU, 
NSC-79037; with Benznidazole.

Arm II:  Single-Agent Chemotherapy.  CCNU; with Placebo, PLCB.

Published Results

Bleehen NM, Freedman LS, Stenning SP: A randomized study of CCNU with and without benznidazole in the treatment of recurrent grades 3 and 4 astrocytoma. Report to the Medical Research Council by the Brain Tumor Working Party. Int J Radiat Oncol Biol Phys 16 (4): 1077-81, 1989.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Medical Research Council Clinical Trials Unit

Norman M. Bleehen, MD, Protocol chair(Contact information may not be current)
Ph: 44-1223-245-151

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.