GliomaEarly Phase 1NCT03193463

Intratumorally-Administered Topotecan Using CED in High Grade Glioma Undergoing Stereotactic Biopsy

A Early Phase 1 study testing Topotecan (<=8cc), Topotecan (>8cc) and Cleveland Multiport Catheter in people with Glioma, run by Michael Vogelbaum, MD, PhD.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Glioma
What is being tested?: Topotecan (<=8cc), Topotecan (>8cc) 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: 0 participants
Where: No sites listed yet
Study dates: 3 Nov 2017to 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 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:
Absolute neutrophil count (ANC) ≥ 1,500 / μL

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Platelet count ≥ 100,000 / μL
Hemoglobin ≥ 10 g / dL
prothrombin time (PT) / partial thromboplastin time (PTT) not above institutional norms
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 cerebrospinal fluid (CSF) disease

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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

About this study

Official title: Pilot Trial 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 (IND 117,240)

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.

Read the detailed description

Primary Objectives

To investigate by MR imaging the spatial and temporal distribution of topotecan in enhancing or nonenhancing bulk tumor 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.
To investigate by MR imaging the influence of the rate and topotecan concentration, on the spatial and temporal distribution of topotecan administered by CED in patients with with recurrent/progressive HGG

Secondary Objectives

To investigate the extent to which backflow may be observed on MRI during CEDmediated delivery of topotecan
To assess the safety, tolerability and toxicity profile of topotecan administered by CED using different doses and 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: Glioma
Being tested: Topotecan (<=8cc), Topotecan (>8cc), Cleveland Multiport Catheter, Magnetic Resonance Imaging (MRI), Lower Does Topotecan
Keywords: Topotecan, Convection-Enhanced Delivery
Medical subject headings: Glioma

What participants receive

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

Topotecan (<=8cc)Drug
Also called Hycamtin
In predominantly enhancing mass with a volume of 8 cc or less of topotecan administered
Topotecan (>8cc)Drug
Also called Hycamtin
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
Cleveland Multiport CatheterDevice
an investigational device, will be used to deliver the topotecan
Magnetic Resonance Imaging (MRI)Diagnostic test
to monitor the infusion of topotecan into the tumor
Lower Does TopotecanDrug
Also called Hycamtin
Rate for non-enhancing tumors has an initial dose of 0.29ml/hour

Study groups in NCT03193463
Study group	Role	What they receive
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. Receives: Drug: Topotecan (<=8cc); Device: Cleveland Multiport Catheter; Diagnostic Test: Magnetic Resonance Imaging (MRI)
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. Receives: Drug: Topotecan (>8cc); Device: Cleveland Multiport Catheter; Diagnostic Test: Magnetic Resonance Imaging (MRI)
Predominantly non-enhancing mass	Experimental	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. Receives: Device: Cleveland Multiport Catheter; Diagnostic Test: Magnetic Resonance Imaging (MRI); Drug: Lower Does Topotecan

What is being measured

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

Number of intra-operative catheter related complications
Documentation of possible, probable, or definite catheter-related complications
Measured: Up to 12 months
Number of post-operative catheter related complications
Documentation of possible, probable, or definite catheter-related complications
Measured: Up to 12 months
Number of catheter related complications after catheter removal
Documentation of possible, probable, or definite catheter-related complications
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 12 months

Secondary outcomes (2)

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)
Measured: Up to 12 months
Safety as measured by the common terminology criteria for adverse events (CTCAE)
Safety will be determined through adverse events by arm
Measured: Up to 12 months

Timeline

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

3 Nov 201719 Nov 2018

First posted20 Jun 2017
Study start3 Nov 2017
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 GliomaStudies 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: Non-randomised
Intervention model: Parallel groups
Model description: 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
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03193463
Sponsor's protocol ID: INFT1317
Status last verified: Feb 2019
First submitted: 13 Jun 2017
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?

Official record

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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: Pilot Trial 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 (IND 117,240)
ClinicalTrials.gov ID: NCT03193463
Acronym / sponsor ID: INFT1317
Conditions: Glioma
Keywords: Topotecan, Convection-Enhanced Delivery
Phase: Early Phase 1
Study type: Interventional
Recruitment status: WithdrawnReason stopped: PI left institution
Enrolment: 0 participants (actual)
Lead sponsor: Michael Vogelbaum, MD, PhDUniversity, hospital or other
Collaborators: Infuseon Therapeutics, Inc.
Study start: 3 Nov 2017 (actual)
Primary completion: 19 Nov 2018 (actual)
Study completion: 19 Nov 2018 (actual)
First posted: 20 Jun 2017 (actual)
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 MR imaging the spatial and temporal distribution of topotecan in enhancing or nonenhancing bulk tumor 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.
To investigate by MR imaging the influence of the rate and topotecan concentration, on the spatial and temporal distribution of topotecan administered by CED in patients with with recurrent/progressive HGG

Secondary Objectives

To investigate the extent to which backflow may be observed on MRI during CEDmediated delivery of topotecan
To assess the safety, tolerability and toxicity profile of topotecan administered by CED using different doses and 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: 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

Arm	Type	Receives
Predominantly enhancing mass with volume of 8 cc or less	Experimental	Drug: Topotecan (<=8cc), Device: Cleveland Multiport Catheter, Diagnostic Test: Magnetic Resonance Imaging (MRI)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.
Predominantly enhancing mass with volume of > 8 cc	Experimental	Drug: Topotecan (>8cc), Device: Cleveland Multiport Catheter, Diagnostic Test: Magnetic Resonance Imaging (MRI)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.
Predominantly non-enhancing mass	Experimental	Device: Cleveland Multiport Catheter, Diagnostic Test: Magnetic Resonance Imaging (MRI), Drug: Lower Does TopotecanThe 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.

Who may qualify

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

Key inclusion criteria (10 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 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:

Key exclusion criteria (13 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
Topotecan (<=8cc)Also: HycamtinIn predominantly enhancing mass with a volume of 8 cc or less of topotecan administered	Drug	Predominantly enhancing mass with volume of 8 cc or less
Topotecan (>8cc)Also: HycamtinIn 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	Drug	Predominantly enhancing mass with volume of > 8 cc
Cleveland Multiport Catheteran investigational device, will be used to deliver the topotecan	Device	Predominantly enhancing mass with volume of 8 cc or less, Predominantly enhancing mass with volume of > 8 cc, Predominantly non-enhancing mass
Magnetic Resonance Imaging (MRI)to monitor the infusion of topotecan into the tumor	Diagnostic test	Predominantly enhancing mass with volume of 8 cc or less, Predominantly enhancing mass with volume of > 8 cc, Predominantly non-enhancing mass
Lower Does TopotecanAlso: HycamtinRate for non-enhancing tumors has an initial dose of 0.29ml/hour	Drug	Predominantly non-enhancing mass

Primary outcome

Number of intra-operative catheter related complications
Time frame: Up to 12 months
Documentation of possible, probable, or definite catheter-related complications
Number of post-operative catheter related complications
Time frame: Up to 12 months
Documentation of possible, probable, or definite catheter-related complications
Number of catheter related complications after catheter removal
Time frame: Up to 12 months
Documentation of possible, probable, or definite catheter-related complications
Change in the spatial distribution of intratumorally-administered topotecan at serial timepoints using a gadolinium-based contrast agent, as determined by MRI scan
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 12 months

2 secondary outcomes

Number of Participants with response as measured by the Response Assessment in Neuro-Oncology (RANO) Criteria
Time frame: Up to 12 months
Safety as measured by the common terminology criteria for adverse events (CTCAE)
Time frame: Up to 12 months

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

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

Related trials for Glioma

Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
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Low Grade Astrocytoma, Low Grade Glioma
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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

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Topotecan (<=8cc), Topotecan (>8cc) and Cleveland Multiport Catheter in people with Glioma, run by Michael Vogelbaum, MD, PhD.

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 10 inclusion and 13 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: withdrawn, 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.

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 withdrawn before enrolling participants, so there are no results.

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?

Number of intra-operative catheter related complications (time frame: Up to 12 months). The study lists 9 primary outcomes in all. 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 NCT03193463.

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.