Taurolidine in Treating Patients With Recurrent or Progressive Glioma

NCT ID: NCT00022360

Last Updated: 2013-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-05-31
• Study Completion Date: 2001-10-31

Brief 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.

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.

Conditions

Brain and Central Nervous System Tumors

Study Design

• Primary Study Purpose: TREATMENT

Interventions

taurolidine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Jeffrey J. Raizer, MD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

CDR0000068808

Identifier Type: REGISTRY

Identifier Source: secondary_id

WALLACE-393

Identifier Type: -

Identifier Source: secondary_id

NCI-G01-2000

Identifier Type: -

Identifier Source: secondary_id

MSKCC-01057

Identifier Type: -

Identifier Source: org_study_id