Status:
COMPLETED
Topotecan Using Convection-Enhanced Delivery (CED) in High Grade Glioma
Lead Sponsor:
Michael Vogelbaum, MD, PhD
Collaborating Sponsors:
Infuseon Therapeutics, Inc.
Conditions:
Malignant Glioma
WHO Grade III or IV Recurrent Glioma
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
Topotecan is a FDA-approved drug when given by intravenous injection, but it is not effective against brain tumors when given intravenously. The Cleveland Multiport Catheter is a new, investigational ...
Detailed Description
This study will look at the way topotecan is injected into participant's tumor. A small amount of contrast dye (called gadolinium DTPA) will be added to topotecan before it is injected. Pictures will ...
Eligibility Criteria
Inclusion
- Histologically confirmed diagnosis of supratentorial WHO Grade III or IV (High Grade Glioma) that has undergone surgical biopsy or resection followed by adjuvant chemoradiotherapy, that has evidence of recurrence or progression based on imaging studies and a stereotactic biopsy is indicated for confirmation of recurrence/progression
- Karnofsky Performance Status 70-100
- MRI demonstration of a stereotactically accessible enhancing mass of less than 40cm3 that does not require resection to relieve clinically significant mass effect
- Patient understands the procedures and agrees to comply with the study requirements by providing written informed consent
- Laboratory values within the following ranges:
- Absolute neutrophil count (ANC)≥1,500/microliter
- Platelet count≥100,000/microliter
- Hemoglobin≥10g/dL
- Normal PT/PTT
- Estimated glomerular filtration rate (eGFR) of at least 50mL/min
Exclusion
- Patient is mentally or legally incapacitated at the time of the study
- Known HIV(+) or has been diagnosed with AIDS
- Participation in another investigational drug study in the prior 4 weeks
- Positive pregnancy test in a female
- Patient, in the opinion of the investigator, is likely to be poorly compliant
- Diffuse subependymal or CSF disease
- Tumors involving the cerebellum
- Tumor enhancement involving both hemispheres
- Active infection requiring treatment
- Unexplained febrile illness
- Radiation or chemotherapy within 4 weeks of enrollment
- Systemic diseases associated with unacceptable anesthesia or operative risk
- Inability to undergo magnetic resonance imaging
Key Trial Info
Start Date :
December 9 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 10 2015
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT02278510
Start Date
December 9 2014
End Date
November 10 2015
Last Update
March 31 2017
Active Locations (1)
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1
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195