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Taurolidine in Treating Patients With Recurrent or Progressive Glioma

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00022360
  Purpose

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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: taurolidine
Phase I

MedlinePlus related topics:   Cancer   

Drug Information available for:   Taurolidine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   An Open-Label Dose-Ranging Study of the Safety of Taurolidine 2% Solution Administered Intravenously to Patients With Recurrent or Progressive High Grade Glioma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   May 2001

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00022360

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center    
      New York, New York, United States, 10021

Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Jeffrey J. Raizer, MD     Memorial Sloan-Kettering Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000068808, MSKCC-01057, WALLACE-393, NCI-G01-2000
First Received:   August 10, 2001
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00022360
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent adult brain tumor  
adult glioblastoma  
adult anaplastic astrocytoma  
adult giant cell glioblastoma  
adult gliosarcoma  

Study placed in the following topic categories:
Brain Neoplasms
Glioblastoma
Taurolidine
Astrocytoma
Glioma
Central Nervous System Neoplasms
Gliosarcoma
Recurrence
Nervous System Neoplasms

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Infective Agents, Local
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Nervous System Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 19, 2008




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