Intratumorally-Administered Topotecan Using Convection-Enhanced Delivery in Patients With Grade III/ IV Glioma
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| ClinicalTrials.gov Identifier: NCT03927274 |
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Recruitment Status :
Recruiting
First Posted : April 25, 2019
Last Update Posted : May 14, 2021
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Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
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Brief Summary:
The purpose of this study is to determine if treatment with Topotecan by an alternative method, delivering topotecan directly into brain tumors, is safe and well tolerated.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Glioma of Brain | Drug: Topotecan | Early Phase 1 |
| Study Type : | Interventional |
| Estimated Enrollment : | 5 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Study of Intratumorally-Administered Topotecan Using Convection-Enhanced Delivery (CED) in Patients With Suspected Recurrent/Progressive World Health Organization (WHO) Grade III or IV (High Grade) Glioma Undergoing Stereotactic Biopsy |
| Actual Study Start Date : | June 20, 2019 |
| Estimated Primary Completion Date : | December 2021 |
| Estimated Study Completion Date : | December 2022 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Cleveland Multiport Catheter (CMC) + Topotecan
For predominantly enhanced tumors with volume of 8 cc or less, only 1 Cleveland Multiport Catheter (CMC) will be placed and convection-enhanced delivery (CED) will be performed over a 4-hour period within an MRI scanner, with the goal of complete tumor coverage (as evidenced by tracer distribution on MRI). The initial rate will be 1.20 ml/hour (5.0 microliters/minute/microcatheter) 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 5 microliters/minute/microcatheter based upon the tumor coverage and safety characteristics of the previously treated patients.
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Drug: Topotecan
Intratumorally-administered topotecan using convection-enhanced delivery (CED) in patients with suspected recurrent/progressive High Grade Glioma (HGG) requiring stereotactic biopsy and is focused on investigating topotecan brain tissue distribution and determining the safety, toxicity, and tolerability of intratumorally-administered topotecan. |
Primary Outcome Measures :
- Distribution of topotecan in tumor tissue [ Time Frame: Treatment day 1 ]The spatial distribution of intratumorally-administered topotecan will be determined using a gadolinium-based contrast agent, volumetric magnetic resonance imaging, and three-dimensional image reconstruction.
Secondary Outcome Measures :
- Number of Adverse Events (AEs) experienced by participants [ Time Frame: Up to 48 weeks ]
- Extent of topotecan backflow [ Time Frame: Treatment day 1 ]Investigate the extent to which backflow may be observed on MRI during CED-mediated delivery of topotecan
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
- 18 years of age or older
- Karnofsky Performance Status 70-100;
- MRI demonstration of a stereotactically accessible enhancing or predominantly non- enhancing mass that does not require resection to relieve clinically significant mass effect;
- Participant understands the procedures and agrees to comply with the study requirements by providing written informed consent
- Adequate organ function as indicated in protocol
Exclusion Criteria:
- Participant 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 Cerebral Spinal Fluid (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 (MRI)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927274
Contacts
| Contact: Jerry Owens | 813-745-1656 | Jerry.Owens@Moffitt.org |
Locations
| United States, Florida | |
| Moffitt Cancer Center | Recruiting |
| Tampa, Florida, United States, 33612 | |
| Contact: Jerry Owens 813-745-1656 Jerry.Owens@Moffitt.org | |
| Contact Jerry.Owens@Moffitt.org | |
| Principal Investigator: Michael Vogelbaum, MD, PhD | |
| Sub-Investigator: Peter Forsyth, M.D. | |
| Sub-Investigator: James Liu, M.D. | |
| Sub-Investigator: Sepideh Mokhtari, M.D | |
| Sub-Investigator: Edwin Peguero, M.D | |
| Sub-Investigator: Solmaz Sahebjam, M.D | |
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
| Principal Investigator: | Michael Vogelbaum, M.D, PhD | Moffitt Cancer Center |
Additional Information:
| Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute |
| ClinicalTrials.gov Identifier: | NCT03927274 |
| Other Study ID Numbers: |
MCC-19970 |
| First Posted: | April 25, 2019 Key Record Dates |
| Last Update Posted: | May 14, 2021 |
| Last Verified: | May 2021 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
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Glioma Brain Tumor High Grade Glioma |
Additional relevant MeSH terms:
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Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
Glioma Topotecan Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |