Topotecan in Treating Patients With Refractory or Progressive Primary Malignant Brain Tumors
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...
Brief Summary
Official Title: “A Phase I Study of Topotecan by Convection Enhanced Delivery (Intracerebral Clysis) for the Treatment of Recurrent Primary Malignant Brain Tumors”
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.
- Study Type: Interventional
- Study Design: Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: January 2009
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: topotecan hydrochloride
Outcome Measures for this Clinical Trial
Primary Measures
- Safety and efficacy
- Safety Issue?: Yes
- Optimizing of treatment parameters and determining volume of drug distribution
- Safety Issue?: No
- Response influence of topoisomerase target expression in tumor
- Safety Issue?: No
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 1 Year
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Herbert Irving Comprehensive Cancer Center Other
Overall Clinical Trial Officials and Contacts
Jeffrey N. Bruce, MD Study Chair Herbert Irving Comprehensive Cancer Center
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00324844
Study ID Number: CDR0000476583
ClinicalTrials.gov Identifier: NCT00324844
Health Authority: Unspecified
Clinical trial summary from the National Cancer Institute's PDQ® database
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00324844
