Taurolidine in Treating Patients With Recurrent or Progressive Glioma

Brain and Central Nervous System Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00022360
• Other study ID #: MSKCC-01057
• Secondary ID: CDR0000068808WAL
• Status: Completed
• Phase: Phase 1
• First received: August 10, 2001
• Last updated: June 17, 2013
• Start date: May 2001
• Est. completion date: October 2001

Study information

• Verified date: June 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2001
• Est. primary completion date: October 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Nervous System Neoplasms

Intervention

Drug:
• taurolidine

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,