Intratumorally-Administered Topotecan Using Convection-Enhanced Delivery in Patients With Grade III/ IV Glioma

NCT03927274 | Terminated Early Phase 1 FDA Drug

• 1 other identifier: MCC-19970
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioma of Brain

Keywords

Glioma; Brain Tumor; High Grade Glioma

Outcome Measures

Primary Outcomes (1)

• Distribution of topotecan in tumor tissue

  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.

  Treatment day 1

Secondary Outcomes (2)

• Number of Adverse Events (AEs) experienced by participants

  Up to 48 weeks

• Extent of topotecan backflow

  Treatment day 1

Study Arms (1)

Cleveland Multiport Catheter (CMC) + Topotecan

EXPERIMENTAL

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.

Drug: Topotecan

Interventions

Topotecan DRUG

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.

Cleveland Multiport Catheter (CMC) + Topotecan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Related Links

• Moffitt Cancer Center Clinical Trials Website

MeSH Terms

Conditions

Glioma; Brain Neoplasms

Interventions

Topotecan

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Michael Vogelbaum, M.D, PhD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: April 25, 2019
• Study Start: June 20, 2019
• Primary Completion: May 24, 2023
• Study Completion: May 24, 2023
• Last Updated: May 25, 2023

Record last verified: 2023-05

Locations

US (1)