RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of acridine carboxamide in treating patients who have recurrent glioblastoma multiforme.

Condition	Treatment or Intervention	Phase
recurrent adult brain tumor adult glioblastoma multiforme	Drug: acridine carboxamide	Phase II

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.

PROTOCOL 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.

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

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL 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

United Kingdom, Scotland
      Beatson Oncology Centre, Glasgow,  Scotland,  G11 6NT,  United Kingdom

Study chairs or principal investigators

Chris Twelves,  Study Chair,  EORTC Early Clinical Studies Group   

Study ID Numbers:  CDR0000067625; EORTC-16991G; XENOVA-XR5000/014/98
Record last reviewed:  August 2004
Record first received:  March 7, 2000
ClinicalTrials.gov Identifier:  NCT00004937
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-22