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Taurolidine in Treating Patients With Recurrent or Progressive Glioma
This study is ongoing, but not recruiting participants.
Study NCT00022360   Information provided by National Cancer Institute (NCI)
First Received: August 10, 2001   Last Updated: July 23, 2008   History of Changes

August 10, 2001
July 23, 2008
May 2001
 
 
 
Complete list of historical versions of study NCT00022360 on ClinicalTrials.gov Archive Site
 
 
 
Taurolidine in Treating Patients With Recurrent or Progressive Glioma
An Open-Label Dose-Ranging Study of the Safety of Taurolidine 2% Solution Administered Intravenously to Patients With Recurrent or Progressive High Grade Glioma

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

PURPOSE: Phase I trial to study the effectiveness of taurolidine in treating patients who have recurrent or progressive glioma.

OBJECTIVES: I. Determine the maximum tolerated dose of taurolidine in patients with recurrent or progressive high-grade glioma. II. Determine the safety and toxicity of this drug in these patients. III. Determine the pharmacokinetics of this drug in these patients. IV. Determine the response in patients treated with this drug.

OUTLINE: This is a dose-escalation study. Patients receive taurolidine IV over 1-4 hours on days 1-5, 8-12, and 15-19. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 1-6 patients receive escalating doses of taurolidine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Patients are followed monthly for 3 months.

PROJECTED ACCRUAL: A total of 4-24 patients will be accrued for this study.

Phase I
Interventional
Treatment
Brain and Central Nervous System Tumors
Drug: taurolidine
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

DISEASE CHARACTERISTICS: Histologically confirmed glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma Recurrent or progressive disease after prior cytoreductive surgery, radiotherapy, and adjuvant chemotherapy Ineligible for any additional conventional therapeutic intervention

PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Karnofsky 60-100% Life expectancy: More than 12 weeks Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL AST/ALT less than 3 times upper limit of normal No indication of acute hepatitis or parenchymal liver disease No significant hepatic disease that would preclude study Renal: Creatinine less than 1.7 mg/dL No significant renal disease that would preclude study Cardiovascular: No significant cardiac disease that would preclude study Other: HIV negative No other active malignancy except curatively treated carcinoma in situ of the cervix or basal cell skin cancer No significant psychiatric disease that would preclude study No significant gastrointestinal disease that would preclude study No known hypersensitivity to taurolidine or its excipients Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 2 weeks since prior interferon Chemotherapy: See Disease Characteristics At least 2 weeks since prior vincristine At least 3 weeks since prior temozolomide or procarbazine At least 4 weeks since prior nitrosoureas Concurrent polifeprosan 20 with carmustine implant (Gliadel wafers) allowed Endocrine therapy: At least 2 weeks since prior tamoxifen Concurrent corticosteroids allowed Radiotherapy: See Disease Characteristics At least 2 weeks since prior stereotactic radiosurgery Surgery: See Disease Characteristics Other: Recovered from prior therapy At least 30 days since prior investigational drug At least 2 weeks since other prior noncytotoxic agents No other concurrent experimental agent or protocol

Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00022360
 
CDR0000068808, MSKCC-01057, WALLACE-393, NCI-G01-2000
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Jeffrey J. Raizer, MD Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
December 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP