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

28 febbraio 2019 aggiornato da: Michael Vogelbaum, MD, PhD

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.

Panoramica dello studio

Stato

Ritirato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Fase

  • Prima fase 1

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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
  • 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
    • 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

Exclusion Criteria:

  • 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
  • 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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Predominantly enhancing mass with volume of 8 cc or less
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.
Droga: Topotecan (<=8cc)
In predominantly enhancing mass with a volume of 8 cc or less of topotecan administered
Altri nomi:
  • Hycamtin
Dispositivo: Cleveland Multiport Catheter
an investigational device, will be used to deliver the topotecan
Test diagnostico: Magnetic Resonance Imaging (MRI)
to monitor the infusion of topotecan into the tumor
Sperimentale: Predominantly enhancing mass with volume of > 8 cc
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.
Dispositivo: Cleveland Multiport Catheter
an investigational device, will be used to deliver the topotecan
Test diagnostico: Magnetic Resonance Imaging (MRI)
to monitor the infusion of topotecan into the tumor
Droga: Topotecan (>8cc)
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
Altri nomi:
  • Hycamtin
Sperimentale: Predominantly non-enhancing mass
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.
Dispositivo: Cleveland Multiport Catheter
an investigational device, will be used to deliver the topotecan
Test diagnostico: Magnetic Resonance Imaging (MRI)
to monitor the infusion of topotecan into the tumor
Droga: Lower Does Topotecan
Rate for non-enhancing tumors has an initial dose of 0.29ml/hour
Altri nomi:
  • Hycamtin

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of intra-operative catheter related complications
Lasso di tempo: Up to 12 months
Documentation of possible, probable, or definite catheter-related complications
Up to 12 months
Number of post-operative catheter related complications
Lasso di tempo: Up to 12 months
Documentation of possible, probable, or definite catheter-related complications
Up to 12 months
Number of catheter related complications after catheter removal
Lasso di tempo: Up to 12 months
Documentation of possible, probable, or definite catheter-related complications
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
Lasso di tempo: Up to 12 months
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
Lasso di tempo: Up to 12 months
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
Lasso di tempo: Up to 12 months
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
Lasso di tempo: Up to 12 months
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
Lasso di tempo: Up to 12 months
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
Lasso di tempo: Up to 12 months
Up to 12 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants with response as measured by the Response Assessment in Neuro-Oncology (RANO) Criteria
Lasso di tempo: Up to 12 months
Response includes objective response rate (ORR), median progression-free survival (PFS), proportion progression-free at six months (PFS-6), and median overall survival (OS)
Up to 12 months
Safety as measured by the common terminology criteria for adverse events (CTCAE)
Lasso di tempo: Up to 12 months
Safety will be determined through adverse events by arm
Up to 12 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Michael Vogelbaum, MD, PhD

Collaboratori

Infuseon Therapeutics, Inc.

Investigatori

  • Investigatore principale: Michael A. Vogelbaum, MD, PhD, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

3 novembre 2017

Completamento primario (Effettivo)

19 novembre 2018

Completamento dello studio (Effettivo)

19 novembre 2018

Date di iscrizione allo studio

Primo inviato

13 giugno 2017

Primo inviato che soddisfa i criteri di controllo qualità

17 giugno 2017

Primo Inserito (Effettivo)

20 giugno 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 marzo 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 febbraio 2019

Ultimo verificato

1 febbraio 2019

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • INFT1317

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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