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PI left institution
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| Name | Class |
|---|---|
| Infuseon Therapeutics, Inc. | INDUSTRY |
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The purpose of this study is to determine if treatment with topotecan by an alternative method, direct delivery into brain tumors, is safe and well tolerated. The Cleveland Multiport Catheter is a new, investigational device that will be used to deliver topotecan into your brain tumor. A second purpose of this study is to determine whether the Cleveland Multiport Catheter can be used effectively and safely to deliver topotecan into your brain tumor.
This study will also determine the best dose of topotecan to deliver to your tumor with use of the Cleveland Multiport Catheter and will also examine how your tumor responds to treatment with topotecan.
Primary Objectives
Secondary Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Predominantly enhancing mass with volume of 8 cc or less | Experimental | Only 1 Cleveland Multiport Catheter (CMC) will be placed and CED will be performed intra-operatively only in a magnetic resonance imaging (MRI) equipped Operating Room. Topotecan infusion will be performed over a 4-hour period, with the goal of complete tumor coverage. The initial rate will be 1.20 ml/hour and infusion will be monitored by intermittent MRI imaging. The rate may be adjusted upwards during the infusion, in the event of incomplete tumor coverage, or downwards, if new mass effect is apparent. Following completion of the 4-hour infusion, the CMC will be removed. The initial rate for each subsequent patient may be adjusted upwards in increments of up to 1.20 ml/hour based upon the tumor coverage and safety characteristics of the previously treated patients. |
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| Predominantly enhancing mass with volume of > 8 cc | Experimental | 2 Cleveland Multiport Catheter (CMCs) will be placed and the total infusion rate of Topotecan per CMC to be used for the first 24 hours for the first patient will be 0.834 ml/hour (3.48 microliters/minute/microcatheter). The rate used for the second 24 hours of the infusion will be 1.668 ml/hour. If the first patient does not experience rate-limiting toxicity, then the patient #2's initial infusion rate will start at the highest tolerated rate for patient #1, and the second 24-hour rate for that patient will be increased by 0.834 ml/hour. Each subsequent patient will undergo rate escalation in a similar manner until we observe either: 1) complete coverage of the enhancing tumor by the infused Gadopentetic acid (Gd-DTPA), or 2) rate-limiting toxicity. |
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| Predominantly non-enhancing mass |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topotecan (<=8cc) | Drug | In predominantly enhancing mass with a volume of 8 cc or less of topotecan administered |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of intra-operative catheter related complications | Documentation of possible, probable, or definite catheter-related complications | Up to 12 months |
| Number of post-operative catheter related complications | Documentation of possible, probable, or definite catheter-related complications | Up to 12 months |
| Number of catheter related complications after catheter removal | Documentation of possible, probable, or definite catheter-related complications | Up to 12 months |
| Change in the spatial distribution of intratumorally-administered topotecan at serial timepoints using a gadolinium-based contrast agent, as determined by MRI scan | Up to 12 months | |
| Changes in the spatial distribution of intratumorally-administered topotecan associated with changes in the infusion rate, as determined by MRI scan | Up to 12 months | |
| Changes in the spatial distribution of intratumorally-administered topotecan at serial timepoints using volumetric magnetic resonance imaging, as determined by MRI scan | Up to 12 months | |
| Changes in the spatial distribution of intratumorally-administered topotecan at serial timepoints using three-dimensional image reconstruction, as determined by MRI scan | Up to 12 months | |
| Changes in the spatial distribution of intratumorally-administered topotecan associated with changes in the infusion concentration, as determined by MRI scan |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with response as measured by the Response Assessment in Neuro-Oncology (RANO) Criteria | Response includes objective response rate (ORR), median progression-free survival (PFS), proportion progression-free at six months (PFS-6), and median overall survival (OS) | Up to 12 months |
| Safety as measured by the common terminology criteria for adverse events (CTCAE) |
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Inclusion Criteria:
Histologically confirmed diagnosis of supratentorial WHO Grade III or IV Glioma (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 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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael A. Vogelbaum, MD, PhD | Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Principal Investigator |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D019772 | Topotecan |
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D014054 | Tomography |
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There will be 3 arms to this study, and they will accrue independently of each other as they reflect distinctly separable populations of patients with rHGG.
Arm 1: Predominantly enhancing mass with volume of 8 cc or less. Arm 2: Predominantly enhancing mass with volume of > 8 cc Arm 3: Predominantly non-enhancing mass
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The total infusion rate of Topotecan per Cleveland Multiport Catheter (CMC) to be used for the first 24 hours for the first patient will be 0.29 ml/hour. The rate used for the second 24 hours of the infusion will be 0.58 ml/hour. If the first patient does not experience rate-limiting toxicity, then the patient #2's initial infusion rate will start at the highest tolerated rate for patient #1, and the second 24-hour rate for that patient will be increased by 0.29 ml/hour. Each subsequent patient will undergo rate escalation in a similar manner until we observe either: 1) complete coverage of the non-enhancing tumor by the infused Gd-DTPA, or 2) rate-limiting toxicity. |
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| Topotecan (>8cc) | Drug | In predominantly enhancing mass with a volume of > 8 cc of topotecan administered. Initial rate is 0.834ml/hour with an increase to 1.668 ml/hour at the second infusion |
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| Cleveland Multiport Catheter | Device | an investigational device, will be used to deliver the topotecan |
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| Magnetic Resonance Imaging (MRI) | Diagnostic Test | to monitor the infusion of topotecan into the tumor |
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| Lower Does Topotecan | Drug | Rate for non-enhancing tumors has an initial dose of 0.29ml/hour |
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| Up to 12 months |
| Changes in the spatial distribution of intratumorally-administered topotecan associated with changes in the infusion duration, as determined by MRI scan | Up to 12 months |
Safety will be determined through adverse events by arm |
| Up to 12 months |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D003952 |
| Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |