Topotecan in Treating Patients With Refractory or Progressive Primary Malignant Brain Tumors - Full Text View

Sponsors and Collaborators:	Herbert Irving Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00324844

Purpose

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
Brain and Central Nervous System Tumors	Drug: topotecan hydrochloride	Phase I

MedlinePlus related topics: Brain Cancer Cancer Childhood Brain Tumors

Drug Information available for: Topotecan hydrochloride Topotecan

U.S. FDA Resources

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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Safety and efficacy [ Designated as safety issue: Yes ]
Optimizing of treatment parameters and determining volume of drug distribution [ Designated as safety issue: No ]
Response influence of topoisomerase target expression in tumor [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	September 2003
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Evaluate the safety and effectiveness of convection enhanced delivery (intracerebral clysis [ICC]) therapy comprising topotecan hydrochloride in patients with refractory or progressive primary malignant brain tumors.
Apply advanced MRI as a noninvasive means of optimizing treatment parameters and determining volume of drug distribution with convection enhanced delivery.
Determine whether the expression of the topoisomerase target in the tumor influences response to topotecan hydrochloride.

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.

Eligibility

Ages Eligible for Study:	1 Year and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of refractory or progressive primary malignant brain tumor, meeting the following criteria:
- Tumor must be < 100 mL in volume and stereotactically available
- Disease may involve only 1 cerebral hemisphere
- Prior resection allowed

PATIENT CHARACTERISTICS:

Karnofsky performance status 60-100%
No acute infection
No hepatitis B or C infection
No systemic disease that would interfere with anesthesia

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
At least 4 weeks since prior chemotherapy
At least 4 weeks since prior radiotherapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00324844

Locations

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

Sponsors and Collaborators

Herbert Irving Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Jeffrey N. Bruce, MD

Herbert Irving Comprehensive Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

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

Keywords provided by National Cancer Institute (NCI):

adult pineocytoma
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 mixed glioma
childhood mixed glioma

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Nervous System Diseases
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009