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An Open-Label Dose-Ranging Study of the Safety of Taurolidine 2% Solution Administered Intravenously to Patients With Recurrent or Progressive High Grade Glioma


Phase 1
16 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

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Trial Information

An Open-Label Dose-Ranging Study of the Safety of Taurolidine 2% Solution Administered Intravenously to Patients With Recurrent or Progressive High Grade 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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Jeffrey J. Raizer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

MSKCC-01057

NCT ID:

NCT00022360

Start Date:

May 2001

Completion Date:

October 2001

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult glioblastoma
  • adult anaplastic astrocytoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021