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Acridine Carboxamide in Treating Patients With Recurrent Glioblastoma Multiforme

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
acridine carboxamide
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring recurrent adult brain tumor, adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beatson Oncology Centre

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 7, 2000
Last Updated
July 10, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00004937
Brief Title
Acridine Carboxamide in Treating Patients With Recurrent Glioblastoma Multiforme
Official Title
Open Label Phase II Study on XR5000 Administered as a 5 Day Infusion in Patients With Glioblastoma Multiforme
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
October 1999 (undefined)
Primary Completion Date
May 2000 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
recurrent adult brain tumor, adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
acridine carboxamide

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Twelves, MD, BMedSci, FRCP
Organizational Affiliation
University of Glasgow
Official's Role
Study Chair
Facility Information:
Facility Name
Beatson Oncology Centre
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G11 6NT
Country
United Kingdom

12. IPD Sharing Statement

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Acridine Carboxamide in Treating Patients With Recurrent Glioblastoma Multiforme

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