Topotecan in Glioma Undergoing A Clinically-Indicated Surgical Resection

NCT02500459 | Terminated Early Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: INFT1315
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Topotecan is an FDA-approved drug when given by intravenous infection. The purpose of this study is to determine if treatment with topotecan by an alternative method, direct delivery into the part of the brain where the tumor has spread, is safe and well tolerated. The Cleveland Multiport Catheter is a new, investigational device that will be used to deliver topotecan into tumor-infiltrated brain. A second purpose of this study is to determine whether the Cleveland Multiport Catheter can be used effectively and safely to deliver topotecan into tumor-infiltrated brain. This study will also examine how tumors responds to treatment with topotecan. This study will also look at the way topotecan is injected into tumors-infiltrated brain. A small amount of contrast dye (called gadolinium DTPA) will be added to topotecan before it is injected. Pictures will be taken of the brain with an MRI machine. This will allow the investigators to see where in the tumor-infiltrated brain the topotecan has been injected. This study will collect medical information before, during, and after treatment in order to better understand hot to make this type of procedure accessible to patients.

Conditions

Brain Tumor; High Grade Glioma

Keywords

Topotecan; Cleveland Multiport Catheter; Cancer

Outcome Measures

Primary Outcomes (1)

• Summary of number of adverse events by grade - A measure of treatment safety

  up to 1 year after start of treatment

Secondary Outcomes (3)

• The number of patients with abnormal hematology lab reports

  up to 1 year after start of treatment

• The number of patients with abnormal clinical chemistry lab reports

  up to 1 year after start of treatment

• The number of patients with abnormal coagulation lab reports

  up to 1 year after start of treatment

Study Arms (1)

intraparenchymally-administered topotecan

EXPERIMENTAL

Patients will have topotecan administered directly into the tumor bed using convection-enhanced delivery (CED)

Drug: topotecan; Device: Cleveland Multiport Catheter

Interventions

topotecan DRUG

intraparenchymally-administered topotecan will use the Cleveland Multiport Catheter to directly infuse topotecan into the tumor site of patients with suspected recurrent/progressive high grade glioma (HGG). This drug is already FDA approved to be administered intravenously.

intraparenchymally-administered topotecan

Cleveland Multiport Catheter DEVICE

The Cleveland Multiport Catheter will directly infuse topotecan into the tumor site of patients with suspected recurrent/progressive high grade glioma (HGG). Standard treatment is to adminsiter the drug intravenously.

intraparenchymally-administered 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 surgical resection of the enhancing tumor is clinically indicated.
• Karnofsky Performance Status 70-100;
• MRI demonstration of an enhancing mass of more than 1 cm\^3 and less than 100 cm\^3;
• Patient understands the procedures and agrees to comply with the study requirements by providing written informed consent; and
• Laboratory values within the following ranges:
• Absolute neutrophil count (ANC) ≥ 1,500 / μL;
• Platelet count ≥ 100,000 / μL;
• Hemoglobin ≥ 10 g / dL;
• Estimated glomerular filtration rate (eGFR) of at least 50 mL/min

You may not qualify if:

• 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
• Active infection requiring treatment;
• Unexplained febrile illness;
• Radiation or chemotherapy within 4 weeks of enrollment
• Systemic diseases associated with unacceptable anesthesia or operative risk;
• Personal or family history of bleeding diathesis and a coagulation profile that would preclude patient from undergoing a neurosurgical procedure
• Subject must take anticoagulants, or antiplatelet agents, including NSAIDs that cannot be stopped for surgery
• Inability to undergo magnetic resonance imaging.

Sponsors & Collaborators

• Michael Vogelbaum, MD, PhD: lead
• Infuseon Therapeutics, Inc.: collaborator

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Brain Neoplasms; Glioma; Neoplasms

Interventions

Topotecan

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Michael A Vogelbaum, MD, PhD

  Case Comprehensive 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 INVESTIGATOR
• PI Title: Associate Director of the Brain Tumor and Neuro-Oncology Center

Study Record Dates

• First Submitted: July 15, 2015
• First Posted: July 16, 2015
• Study Start: July 6, 2015
• Primary Completion: November 19, 2018
• Study Completion: November 19, 2018
• Last Updated: March 1, 2019

Record last verified: 2019-02

Locations

US (1)