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Open Label Phase II Study on XR5000 Administered as a 5 Day Infusion in Patients With Glioblastoma Multiforme

Phase 2
18 Years
Not Enrolling
Brain and Central Nervous System Tumors

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Trial Information

Open Label Phase II Study on XR5000 Administered as a 5 Day Infusion in Patients With Glioblastoma Multiforme

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.

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.

Inclusion Criteria

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

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

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Chris Twelves, MD, BMedSci, FRCP

Investigator Role:

Study Chair

Investigator Affiliation:

University of Glasgow


United States: Federal Government

Study ID:




Start Date:

October 1999

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult glioblastoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Glioblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms