Acridine Carboxamide in Treating Patients With Recurrent Glioblastoma Multiforme
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: acridine carboxamide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Open Label Phase II Study on XR5000 Administered as a 5 Day Infusion in Patients With Glioblastoma Multiforme |
| Study Start Date: | October 1999 |
| Primary Completion Date: | May 2000 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United Kingdom | |
| Beatson Oncology Centre | |
| Glasgow, Scotland, United Kingdom, G11 6NT | |
| Study Chair: | Chris Twelves, MD, BMedSci, FRCP | University of Glasgow |
More Information
Additional Information:
No publications provided
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00004937 History of Changes |
| Other Study ID Numbers: | EORTC-16991G, EORTC-16991G, XENOVA-XR5000/014/98 |
| Study First Received: | March 7, 2000 |
| Last Updated: | July 10, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
|
recurrent adult brain tumor adult glioblastoma adult giant cell glioblastoma adult gliosarcoma |
Additional relevant MeSH terms:
|
Glioblastoma Nervous System Neoplasms Central Nervous System Neoplasms Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013