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Home > "T" Clinical Trials Conditions > Taurolidine in Treating Patients With Recurrent or Progressive Glioma  Taurolidine in Treating Patients With Recurrent or Progressive Glioma
Taurolidine in Treating Patients With Recurrent or Progressive Glioma
For Condition: adult glioblastoma multiforme,adult anaplastic astrocytoma,recurrent adult brain tumor
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JeffreyRaizer, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000068808; NCI-G01-2000,MSKCC-01057,WALLACE-393
Study Start Date: May 2001
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00022360
Other Recurrent Adult Brain Tumor Studies:
1. Alanosine in Treating Patients With Progressive or Recurrent Malignant Gliomas
2. BMS 247550 in Treating Patients With Recurrent Glioma
3. Carmustine in Treating Patients With Recurrent Malignant Glioma
4. PEG-Interferon alfa-2b With or Without Thalidomide in Treating Patients With Recurrent High-Grade Gliomas
5. Temozolomide Plus Irinotecan in Treating Patients With Recurrent Malignant Glioma
Related Studies:
Other recurrent adult brain tumor Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Taurolidine in Treating Patients With Recurrent or Progressive Glioma
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