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

Alternate Title

Acridine Carboxamide in Treating Patients With Recurrent Glioblastoma Multiforme

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over EORTC-16991G XENOVA-XR5000/014/98, NCT00004937

Objectives

I.  Determine the efficacy acridine carboxzmide in terms of objective response 
rate and response duration in patients with glioblastoma multiforme.

II.  Determine the toxicities of this treatment regimen in this patient 
population.

Entry Criteria

Disease Characteristics:

Histologically or cytologically confirmed recurrent glioblastoma multiforme
 
Measurable disease on contrast MRI
 Lesion at least 2 cm in diameter

 

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 At least 6 weeks since prior adjuvant chemotherapy for brain tumor
 No other prior chemotherapy

Endocrine therapy:
 Must be on stable or decreasing doses of corticosteroids for at least 2 weeks

Radiotherapy:
 At least 3 months since prior radiotherapy to the brain 
 No prior high dose radiotherapy
 No prior stereotactic boost or implant radiotherapy

Surgery:
 No prior surgery (except biopsy) for recurrent brain tumor
 At least 3 months since prior surgery for primary brain tumor

Other:
 No other concurrent anticancer agents
 No other concurrent investigational therapy

Patient Characteristics:

Age:
 18 and over

Performance status:
 ECOG 0-2
 Karnofsky 70-100%

Life expectancy:
 At least 3 months

Hematopoietic:
 WBC greater than 3,000/mm3
 Platelet count greater than 100,000/mm3

Hepatic:
 Bilirubin less than 1.5 times upper limit of normal (ULN)
 Alkaline phosphatase no greater than 2 times ULN
 Transaminases no greater than 2 times ULN

Renal:
 Creatinine no greater than 1.5 mg/dL

Cardiovascular:
 Normal cardiac function
 No ischemic heart disease within the past 6 months
 Normal electrocardiogram

Other:
 No unstable systemic diseases
 No active uncontrolled infections
 No prior or other concurrent malignancies except adequately treated basal or  
  squamous cell skin cancer or carcinoma in situ of the cervix
 No psychological, familial, sociological, or geographical condition that      
  would preclude study
 Not pregnant or nursing
 Fertile patients must use effective contraception

Expected Enrollment

A total of 14-25 patients will be accrued for this study.

Outline

This is a multicenter study.

Patients receive acridine carboxamide IV continuously over days 1-5. Treatment 
repeats every 3 weeks for at least 2 courses and up to a maximum of 6 courses 
in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 weeks until disease progression.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Chris Twelves, MD, BMedSci, FRCP, Protocol chair(Contact information may not be current)		Ph: 44-141-211-1712

Registry Information
Official Title		Open Label Phase II Study on XR5000 Administered as a 5 Day Infusion in Patients with Glioblastoma Multiforme
Trial Start Date		1999-10-25
Registered in ClinicalTrials.gov		NCT00004937
Date Submitted to PDQ		2000-01-13
Information Last Verified		2000-07-01