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Phase IIb Clinical Trial With TGF-β2 Antisense Compound AP 12009 for Recurrent or Refractory High-grade Glioma

NCT ID: NCT00431561

Last Updated: 2013-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2009-03-31

Brief Summary

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In this multinational dose finding Phase IIb study the efficacy and safety of two doses of AP 12009 compared to standard chemotherapy (temozolomide or PCV) is investigated in adult patients with confirmed recurrent high-grade glioma.

Detailed Description

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The purpose of this study is to compare the safety and efficacy of two doses of AP 12009 and standard chemotherapy in adult patients with recurrent high-grade glioma (anaplastic astrocytoma \[AA\], WHO grade III; or glioblastoma \[GBM\], WHO grade IV). AP 12009 is a phosphorothioate antisense oligodeoxynucleotide specific for the mRNA of human transforming growth factor-beta2 (TGF-beta2). The growth factor TGF-beta plays a key role in malignant progression of various tumors by inducing proliferation, invasion, metastasis, angiogenesis and escape from immunosurveillance. It has been shown that in a number of tumor types the degree of TGF-beta production strongly correlates with tumor grade and stage. In patients with high-grade glioma, the TGF-beta2 overexpression is associated with disease stage, clinical prognosis and the immunodeficient state of the patients.

Conditions

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Glioblastoma Anaplastic Astrocytoma

Keywords

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Glioblastoma Anaplastic astrocytoma Antisense Cancer Transforming growth factor beta2 (TGF-beta2) Targeted therapy Immunotherapy Brain tumor Central nervous system (CNS) Convection-enhanced delivery (CED) / microperfusion Locoregional application

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AP 12009 10 µM

Group Type EXPERIMENTAL

AP 12009 10 µM

Intervention Type DRUG

10 µM AP 12009 (trabedersen), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks

Drug delivery system for administration of AP 12009

Intervention Type DEVICE

Drug delivery system for Convection Enhanced Delivery consists of a portable pump with drug reservoir and infusion line. Main implanted parts are the port access system and the intratumoral catheter.

Placement of Drug Delivery System

Intervention Type PROCEDURE

Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT.

AP 12009 80 µM

Group Type EXPERIMENTAL

AP 12009 80 µM

Intervention Type DRUG

80 µM AP 12009 (trabedersen), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks

Drug delivery system for administration of AP 12009

Intervention Type DEVICE

Drug delivery system for Convection Enhanced Delivery consists of a portable pump with drug reservoir and infusion line. Main implanted parts are the port access system and the intratumoral catheter.

Placement of Drug Delivery System

Intervention Type PROCEDURE

Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT.

Chemotherapy

Group Type ACTIVE_COMPARATOR

temozolomide or PCV

Intervention Type DRUG

temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle; PCV (procarbazine, CCNU, vincristine): standard regimen

Interventions

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AP 12009 10 µM

10 µM AP 12009 (trabedersen), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks

Intervention Type DRUG

AP 12009 80 µM

80 µM AP 12009 (trabedersen), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks

Intervention Type DRUG

temozolomide or PCV

temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle; PCV (procarbazine, CCNU, vincristine): standard regimen

Intervention Type DRUG

Drug delivery system for administration of AP 12009

Drug delivery system for Convection Enhanced Delivery consists of a portable pump with drug reservoir and infusion line. Main implanted parts are the port access system and the intratumoral catheter.

Intervention Type DEVICE

Placement of Drug Delivery System

Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT.

Intervention Type PROCEDURE

Other Intervention Names

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Temodar Temodal TMZ lomustine Cecenu CeeNU

Eligibility Criteria

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Inclusion Criteria

* Histopathologically confirmed diagnosis of recurrent or refractory high-grade glioma (anaplastic astrocytoma, WHO grade III; or glioblastoma, WHO grade IV)
* Supratentorial localization
* No more than two chemotherapy regimens including radiochemotherapy since primary diagnosis
* Eligible for either TMZ or PCV treatment
* Recovery from acute toxicity caused by any previous therapy
* Adequate organ functions
* KPS at least 70%

Exclusion Criteria

* Tumor surgery within 2 weeks prior to study entry
* Radiation therapy within 8 weeks prior to study entry
* Chemotherapy within 4 weeks prior to study entry (nitrosureas: 6 weeks)
* No more than 3 mg/day dexamethasone (or equivalent) at baseline
* Prior TGF-beta targeted therapy or tumor vaccination
* Baseline MRI shows mass effect
* Known active infection with HIV, HBV, or HCV; acute viral, bacterial, or fungal infection
* Significant psychiatric disorders/legal incapacity or a limited legal capacity
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Isarna Therapeutics GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Antisense Pharma

Principal Investigators

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Ulrich Bogdahn, MD

Role: PRINCIPAL_INVESTIGATOR

University of Regensburg, Dept. of Neurology, Germany

Locations

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Universitätsklinik Innsbruck; Abteilung für Neurochirurgie

Innsbruck, , Austria

Site Status

Landes-Nervenklinik Wagner-Jauregg

Linz, , Austria

Site Status

Kaiser Franz Josef Spital, Abteilung für Neurologie

Vienna, , Austria

Site Status

Sarajishvili Institute of Clinical Neurology and Neurosurgery

Tbilisi, , Georgia

Site Status

Medizinische Klinik und Poliklinik mit Schwerpunkt Onkologie und Hämatologie, Charité Campus Mitte

Berlin, , Germany

Site Status

Klinik und Poliklinik für Neurologie

Cottbus, , Germany

Site Status

Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

Dresden, , Germany

Site Status

Universitätsklinikum Gießen, Neurochirurgische Universitätsklinik

Giessen, , Germany

Site Status

Universitätsklinikum Kiel, Klinik für Neurochirurgie

Kiel, , Germany

Site Status

Universitätsklinikum Leipzig, Klinik und Poliklinik für Neurochirurgie

Leipzig, , Germany

Site Status

Universitätsklinik Magdeburg, Klinik für Neurochirurgie

Magdeburg, , Germany

Site Status

Universitätskliniken Mainz, Neurochirurgische Klinik und Poliklinik

Mainz, , Germany

Site Status

Universitätsklinikum Münster, Klinik und Poliklinik für Neurochirurgie

Münster, , Germany

Site Status

Klinikum und Poliklinik für Neurologie, Universität Regensburg

Regensburg, , Germany

Site Status

Klinikum Saarbrücken, Neurochirurgie

Saarbrücken, , Germany

Site Status

Neurologische Universitätsklinik Tübingen

Tübingen, , Germany

Site Status

Department of Neurosurgery, Amrita Institute of Medical Sciences & Research Centre

Kochi, Kerala, India

Site Status

Sree Chitra Tirunal Institute for Medical Sciences & Technology, Department of Neurosurgery

Trivandrum, Kerala, India

Site Status

Manipal Hospital; Manipal Institute for Neurological Disorders

Bangalore, , India

Site Status

Department of Neurosurgery, National Institute of Mental Health and Neurosciences

Bangalore, , India

Site Status

Department of Medical Oncology, Nizam's Institute of Medical Sciences

Hyderabad, , India

Site Status

Department of Neurosurgery, LTMG Hospital & LTM Medical College

Mumbai, , India

Site Status

Department of Neurosurgery, Neurosciences Center

New Dehli, , India

Site Status

Department of Neurological Sciences, Christian Medical College & Hospital

Vellore, , India

Site Status

Soroka Medical Center, Neurosurgery Department

Beersheba, , Israel

Site Status

Rambam Medical Center, Neurosurgery Department

Haifa, , Israel

Site Status

Rabin Medical Center, Neurosurgery Department

Petah Tikva, , Israel

Site Status

Tcheliabinsk Regional Clinical Hospital; State Medical Institution for Prophylaxis and Treatment

Chelyabinsk, , Russia

Site Status

Republican Clinical Hospital of Ministry of Health of Tatarstan Republic

Kazan', , Russia

Site Status

Burdenko Neurosurgery Research Institute

Moscow, , Russia

Site Status

Omsk State Medical Academy; State Educational Institution of Higher Professional Education

Omsk, , Russia

Site Status

Polenov Neurosurgery Research Institute

Saint Petersburg, , Russia

Site Status

Military Medical Academy named after I.S.M. Kirov, Neurosurgery Department

Saint Petersburg, , Russia

Site Status

Medical Center "XXI century"

Saint Petersburg, , Russia

Site Status

State Institution of Healthcare, Samara Regional Clinical Hospital in the name of M.I. Kalinin

Samara, , Russia

Site Status

Sverdlovsk Regional Oncological Clinic

Yekaterinburg, , Russia

Site Status

Countries

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Austria Georgia Germany India Israel Russia

References

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Uckun FM, Qazi S, Hwang L, Trieu VN. Recurrent or Refractory High-Grade Gliomas Treated by Convection-Enhanced Delivery of a TGFbeta2-Targeting RNA Therapeutic: A Post-Hoc Analysis with Long-Term Follow-Up. Cancers (Basel). 2019 Nov 28;11(12):1892. doi: 10.3390/cancers11121892.

Reference Type DERIVED
PMID: 31795071 (View on PubMed)

Other Identifiers

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AP 12009-G004

Identifier Type: -

Identifier Source: org_study_id