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Sponsors and Collaborators: |
Herbert Irving Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00324844 |
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving topotecan directly into the tumor and surrounding tissue may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects of topotecan infused directly into the tumor and surrounding tissue in treating patients with refractory or progressive primary malignant brain tumors.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Drug: topotecan hydrochloride |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I Study of Topotecan by Convection Enhanced Delivery (Intracerebral Clysis) for the Treatment of Recurrent Primary Malignant Brain Tumors |
Estimated Enrollment: | 30 |
Study Start Date: | September 2003 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is an open-label study.
Patients undergo placement of two catheters inserted directly into the tumor and surrounding tissue. Patients receive topotecan hydrochloride via convection enhanced delivery continuously for up to 5 days. Patients are monitored daily for response and drug distribution by MRI.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Ages Eligible for Study: | 1 Year and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of refractory or progressive primary malignant brain tumor, meeting the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, New York | |
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | Recruiting |
New York, New York, United States, 10032 | |
Contact: Clinical Trials Office - Herbert Irving Comprehensive Cancer C 212-305-8615 |
Study Chair: | Jeffrey N. Bruce, MD | Herbert Irving Comprehensive Cancer Center |
Study ID Numbers: | CDR0000476583, CPMC-AAAA-4229, CPMC-14220 |
Study First Received: | May 10, 2006 |
Last Updated: | November 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00324844 |
Health Authority: | Unspecified |
recurrent adult brain tumor recurrent childhood brain tumor adult anaplastic astrocytoma adult anaplastic ependymoma adult anaplastic oligodendroglioma adult central nervous system germ cell tumor adult ependymoblastoma adult giant cell glioblastoma adult glioblastoma adult gliosarcoma adult medulloblastoma adult pineoblastoma adult subependymoma adult supratentorial primitive neuroectodermal tumor (PNET) recurrent childhood ependymoma |
recurrent childhood medulloblastoma childhood central nervous system germ cell tumor childhood oligodendroglioma childhood high-grade cerebral astrocytoma adult diffuse astrocytoma adult pilocytic astrocytoma adult brain stem glioma adult ependymoma adult myxopapillary ependymoma adult papillary meningioma adult melanocytic lesion adult oligodendroglioma adult pineocytoma adult mixed glioma childhood mixed glioma |
Glioblastoma Neuroectodermal Tumors, Primitive Astrocytoma Central Nervous System Diseases Central Nervous System Neoplasms Brain Diseases Recurrence Ependymoma Brain Neoplasms Neuroectodermal Tumors |
Medulloblastoma Neuroepithelioma Oligodendroglioma Meningioma Glioma Topotecan Gliosarcoma Pinealoma Nervous System Neoplasms |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Nervous System Diseases Enzyme Inhibitors Pharmacologic Actions |