Brain TumorEarly Phase 1NCT02500459

Topotecan in Glioma Undergoing A Clinically-Indicated Surgical Resection

A Early Phase 1 study testing topotecan and Cleveland Multiport Catheter in people with Brain Tumor and High Grade Glioma, run by Michael Vogelbaum, MD, PhD at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Brain Tumor, High Grade Glioma
What is being tested?: topotecan and Cleveland Multiport Catheter
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 1 siteUnited States
Study dates: 6 Jul 2015to 19 Nov 2018
Phase: Early Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

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Platelet count ≥ 100,000 / μL;
Hemoglobin ≥ 10 g / dL;
Estimated glomerular filtration rate (eGFR) of at least 50 mL/min

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195

Other trials in United States

About this study

Official title: A Pilot Trial of Intraparenchymally-Administered Topotecan Using Convection-Enhanced Delivery (CED) in Patients With Suspected Recurrent/Progressive WHO Grade III or IV (High Grade) Glioma Undergoing A Clinically-Indicated Surgical Resection (IND 117,240)

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.

Read the detailed description

Primary Objectives

To investigate by magnetic resonance (MR) imaging the spatial and temporal distribution of topotecan in tumor-infiltrated brain administered by convection-enhanced delivery (CED) in patients with recurrent/progressive WHO grade III or IV (high grade) glioma (HGG) who have failed standard therapy comprising surgical biopsy and/or resection and adjuvant chemotherapy and radiotherapy, following a clinically-indicated resection of the contrast enhancing tumor mass.
To investigate by MR imaging the influence of catheter positioning, on the spatial and temporal distribution of topotecan administered by CED in patients with recurrent/progressive HGG
To evaluate the extent of spatial distribution of topotecan, by MR imaging, when delivered into non-enhancing tumor tissue (as defined on pre-operative conventional MRI imaging with and without intravenous gadolinium) in the intraoperative setting, the immediate peri-operative setting, and in the post-operative setting.

Secondary Objectives

To investigate the extent to which CED-mediated delivery of topotecan
To investigate the extent to which infusate can be distributed in the 2 cm margin around the resection cavity by administration by CED
To assess the safety, tolerability and toxicity profile of topotecan administered by CED using different infusion rates.
To observe evidence of activity of single-agent topotecan administered by CED to patients with recurrent/progressive HGG who have failed standard therapy comprising surgical biopsy and/or resection and adjuvant chemotherapy and radiotherapy.

Conditions: Brain Tumor, High Grade Glioma
Being tested: topotecan, Cleveland Multiport Catheter
Keywords: Topotecan, Cleveland Multiport Catheter, Cancer
Medical subject headings: Brain Neoplasms, Glioma, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

topotecanDrug
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.
Cleveland Multiport CatheterDevice
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.

Study groups in NCT02500459
Study group	Role	What they receive
intraparenchymally-administered topotecan	Experimental	Patients will have topotecan administered directly into the tumor bed using convection-enhanced delivery (CED) Receives: Drug: topotecan; Device: Cleveland Multiport Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

Summary of number of adverse events by grade - A measure of treatment safety
Measured: up to 1 year after start of treatment

Secondary outcomes (3)

The number of patients with abnormal hematology lab reports
Measured: up to 1 year after start of treatment
The number of patients with abnormal clinical chemistry lab reports
Measured: up to 1 year after start of treatment
The number of patients with abnormal coagulation lab reports
Measured: up to 1 year after start of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jul 201519 Nov 2018

First posted16 Jul 2015 (estimated)
Study start6 Jul 2015
Primary completion19 Nov 2018
Study completion19 Nov 2018

Why it stopped: PI Left institution

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Brain TumorStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02500459
Sponsor's protocol ID: INFT1315
Status last verified: Feb 2019
First submitted: 15 Jul 2015
Last updated: 1 Mar 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Trial of Intraparenchymally-Administered Topotecan Using Convection-Enhanced Delivery (CED) in Patients With Suspected Recurrent/Progressive WHO Grade III or IV (High Grade) Glioma Undergoing A Clinically-Indicated Surgical Resection (IND 117,240)
ClinicalTrials.gov ID: NCT02500459
Acronym / sponsor ID: INFT1315
Conditions: Brain Tumor, High Grade Glioma
Keywords: Topotecan, Cleveland Multiport Catheter, Cancer
Phase: Early Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: PI Left institution
Enrolment: 9 participants (actual)
Lead sponsor: Michael Vogelbaum, MD, PhDUniversity, hospital or other
Collaborators: Infuseon Therapeutics, Inc.
Study start: 6 Jul 2015 (actual)
Primary completion: 19 Nov 2018 (actual)
Study completion: 19 Nov 2018 (actual)
First posted: 16 Jul 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Primary Objectives

To investigate by magnetic resonance (MR) imaging the spatial and temporal distribution of topotecan in tumor-infiltrated brain administered by convection-enhanced delivery (CED) in patients with recurrent/progressive WHO grade III or IV (high grade) glioma (HGG) who have failed standard therapy comprising surgical biopsy and/or resection and adjuvant chemotherapy and radiotherapy, following a clinically-indicated resection of the contrast enhancing tumor mass.
To investigate by MR imaging the influence of catheter positioning, on the spatial and temporal distribution of topotecan administered by CED in patients with recurrent/progressive HGG
To evaluate the extent of spatial distribution of topotecan, by MR imaging, when delivered into non-enhancing tumor tissue (as defined on pre-operative conventional MRI imaging with and without intravenous gadolinium) in the intraoperative setting, the immediate peri-operative setting, and in the post-operative setting.

Secondary Objectives

To investigate the extent to which CED-mediated delivery of topotecan
To investigate the extent to which infusate can be distributed in the 2 cm margin around the resection cavity by administration by CED
To assess the safety, tolerability and toxicity profile of topotecan administered by CED using different infusion rates.
To observe evidence of activity of single-agent topotecan administered by CED to patients with recurrent/progressive HGG who have failed standard therapy comprising surgical biopsy and/or resection and adjuvant chemotherapy and radiotherapy.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
intraparenchymally-administered topotecan	Experimental	Drug: topotecan, Device: Cleveland Multiport CatheterPatients will have topotecan administered directly into the tumor bed using convection-enhanced delivery (CED)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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:

Key exclusion criteria (14 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
topotecanintraparenchymally-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.	Drug	intraparenchymally-administered topotecan
Cleveland Multiport CatheterThe 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.	Device	intraparenchymally-administered topotecan

Primary outcome

Summary of number of adverse events by grade - A measure of treatment safety
Time frame: up to 1 year after start of treatment

3 secondary outcomes

The number of patients with abnormal hematology lab reports
Time frame: up to 1 year after start of treatment
The number of patients with abnormal clinical chemistry lab reports
Time frame: up to 1 year after start of treatment
The number of patients with abnormal coagulation lab reports
Time frame: up to 1 year after start of treatment

Results and safety

The study was stopped early (reason given: PI Left institution). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael A Vogelbaum, MD, PhD principal investigator

Case Comprehensive Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing topotecan and Cleveland Multiport Catheter in people with Brain Tumor and High Grade Glioma, run by Michael Vogelbaum, MD, PhD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: PI Left institution). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Summary of number of adverse events by grade - A measure of treatment safety (time frame: up to 1 year after start of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02500459.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2019.