Glufosfamide in Treating Patients With Recurrent Glioblastoma Multiforme

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC (Other)

Overall Status

Completed

CT.gov ID

NCT00014300

Collaborator

(none)

Enrollment

Locations

1.8

Patients Per Site

Study Details

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 glufosfamide in treating patients who have recurrent glioblastoma multiforme.

Condition or Disease	Intervention/Treatment	Phase
Brain and Central Nervous System Tumors	Drug: glufosfamide	Phase 2

Detailed Description

OBJECTIVES: I. Determine the activity of glufosfamide, in terms of objective response rate and/or progression-free survival at 6 months, in patients with recurrent glioblastoma multiforme. II. Determine the duration of objective response in patients treated with this regimen. III. Determine the toxic effects and pharmacokinetic profile of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients receive glufosfamide IV over 60 minutes on day

Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients with stable disease receive treatment for a minimum of 6 months or until progression. Patients with an objective complete response receive a maximum of 2 additional courses of treatment after confirmation of response. Patients are followed every 6 weeks until progression.

PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Primary Purpose:

Treatment

Official Title:

Open Label Phase II Study On Glufosfamide Administered As A 60 Minute Infusion Every 3 Weeks In Recurrent Glioblastoma Multiforme

Study Start Date :

Jan 1, 2001

Actual Primary Completion Date :

Sep 1, 2001

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed glioblastoma multiforme Recurrent disease by CT scan or MRI At least 1 bidimensionally measurable target lesion at least 2 cm in the largest diameter

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2.5 times ULN AST and ALT no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min Cardiovascular: Cardiac function normal No history of ischemic heart disease within the past 6 months 12 lead ECG normal Other: No other prior or concurrent malignancy except cone biopsied cervical cancer or adequately treated basal cell or squamous cell skin cancer No unstable systemic disease No active uncontrolled infection 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: No concurrent prophylactic growth factors (e.g., filgrastim (G-CSF)) Chemotherapy: No more than 1 prior chemotherapy regimen as adjuvant therapy or for recurrent disease At least 6 weeks since prior chemotherapy Endocrine therapy: Stable or decreasing dose of corticosteroids for at least 1 week prior to study Radiotherapy: At least 3 months since prior radiotherapy to the brain No prior high-dose radiotherapy (more than 65 Gy), stereotactic radiosurgery, or internal radiotherapy unless the disease recurrence is histologically confirmed 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 agents

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Kaiser Franz Josef Hospital	Vienna (Wien)	Austria	A-1100
2	Centre Jean Perrin	Clermont-Ferrand	France	63011
3	Centre de Lute Contre le Cancer,Georges-Francois Leclerc	Dijon	France	21079
4	Centre Leon Berard	Lyon	France	69373
5	CRLCC Nantes - Atlantique	Nantes-Saint Herblain	France	44805
6	Centre Antoine Lacassagne	Nice	France	06189
7	CHU Pitie-Salpetriere	Paris	France	75651
8	Centre Eugene Marquis	Rennes	France	35064
9	Institut Gustave Roussy	Villejuif	France	F-94805
10	University of Ioannina	Ioannina	Greece	GR-45110
11	Schneider Children's Medical Center of Israel	Petah-Tikva	Israel	49202
12	Azienda Ospedaliera di Padova	Padova (Padua)	Italy	35128
13	Istituti Fisioterapici Ospitalieri - Roma	Rome	Italy	00161
14	Rotterdam Cancer Institute	Rotterdam	Netherlands	3075 EA
15	Academisch Ziekenhuis Utrecht	Utrecht	Netherlands	3508 GA
16	Instituto Portugues de Oncologia de Francisco Gentil	Lisbon	Portugal	1093
17	Centre Hospitalier Universitaire Vaudois	Lausanne	Switzerland	CH-1011
18	Kantonsspital - St. Gallen	St. Gallen	Switzerland	CH-9007