Clinical Study of OncoSorb® in Patients With Advanced Cancer Entities (BP-005)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01013168
Recruitment Status : Terminated (Achievement of feasibility and safety without achievement of clinical response.)
First Posted : November 13, 2009
Last Update Posted : July 22, 2011
Dr. M. Koehler GmbH
ARTIMED Medical Consulting GmbH
Information provided by:
BioPheresis GmbH

Brief Summary:
The purpose of this study is to collect further data for safety and feasibility for the use of the medical device OncoSorb® in clinical routine for the treatment of patients with solid metastatic cancer entities who have failed standard therapies. OncoSorb® device is intended to specifically adsorb three soluble receptors (sTNF-R1, sTNF-R2 and sIL-2R α), which are known to inhibit the natural immune response of cancer patients mediated via tumor necrosis factor α (TNF- α).

Condition or disease Intervention/treatment Phase
Advanced Cancer Entities Procedure: Apheresis using the OncoSorb column Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of OncoSorb® in Patients With Advanced Cancer Entities
Study Start Date : August 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : February 2011

Arm Intervention/treatment
Experimental: OncoSorb® column Procedure: Apheresis using the OncoSorb column
device is intended to specifically adsorb three soluble receptors (sTNF-R1, sTNF-R2 and sIL-2R α)
Other Name: BioPheresis OncoSorb® system

Primary Outcome Measures :
  1. Occurrence of: possible catheter infection, suitability of citrate/heparin anticoagulation, adverse events/serious adverse events in general [ Time Frame: 0-6 months ]

Secondary Outcome Measures :
  1. Overall response defined by RECIST criteria [ Time Frame: 8 week response rate ]
  2. Quality of life questionaire (as assessed by EORTC QLQ-C30 rev. 3.0) [ Time Frame: 0-6 months ]
  3. Kinetics of sTNF-R1, sTNF-R2 and sIL-2R α [ Time Frame: receptor levels will be measured on treatment day 4 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with metastatic solid cancer who have documented progressive disease and who have failed standard therapy
  • Measurable disease (RECIST criteria)
  • Expected survival of at least 4 months
  • Performance status ECOG 0 and 1
  • Vital laboratory parameters within normal range, or protocol specified ranges
  • Able to give written informed consent
  • The patient's sTNF-R1, sTNF-R2 levels in citrate plasma are > 500 pg/ml and > 1000 pg/ml respectively
  • The patient has adequate renal function as evidenced by glomerular filtration rate > 80 ml/min
  • Patient 5 with metastatic melanoma must have skin lesion(s)
  • Patient 5 with metastatic melanoma should have slow tumor progression
  • Patient 5 with metastatic melanoma must have an intact TNF-receptor signaling cascade, resulting in measurable induction of cancer cell apoptosis following the exposition to TNF-α in vitro. This will be evidenced by destruction of primary autologous cancer cells obtained by biopsy.

Exclusion Criteria:

  • Other serious or significant illnesses
  • Other malignancy within the last 3 years, except for target oncological indication (does not exclude metastatic sites)
  • Known immunodeficiency
  • Known HIV or hepatitis positivity
  • Using systemic immunosuppressive drugs. (Exceptions: Specific COX-2 inhibitors; low dose aspirin for cardiovascular event prevention; topical/inhaled steroids)
  • Chemotherapy, immunotherapy or radiotherapy within two weeks prior to start of OncoSorb® treatments provided that all prior therapy related toxicities are resolved
  • Participation in a prior clinical trial involving an investigational agent within the last 2 weeks
  • Not available for clinical follow-up assessments
  • Pregnancy or breastfeeding
  • Refusal or inability to use effective means of contraception for women of childbearing potential
  • Mental impairment that may compromise ability to give informed consent and to comply with study requirements
  • History of a myocardial infarction within 6 months prior to the start of study, uncontrolled congestive heart failure, or any current Grade 3 or 4 cardiovascular disorder despite treatment
  • Coagulation disorders and / or a history of thromboembolic complications
  • Any significant disease that, in the Investigator's opinion, should exclude the patient from the study
  • Known hypersensitivity or allergy to rabbit proteins
  • Known hypersensitivity to heparin or citrate
  • The patient receives Angiotensin-Converting Enzyme (ACE) inhibitors or Coumadin (Marcumar®) as concomitant medication
  • Patient 5 with metastatic melanoma with brain metastases (MRT scan)
  • Patient 5 with metastatic melanoma is severely immunocompromised (patient must have average or low TREG counts, no dysfunctional T cells like e.g. CD28-)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01013168

St. Josefskrankenhaus
Heidelberg, Baden-Württemberg, Germany, 69115
Dermatologische Onkologie am NCT
Heidelberg, Baden-Württemberg, Germany, 69120
Nationales Centrum für Tumorerkrankungen (NCT)
Heidelberg, Baden-Württemberg, Germany, 69120
Nierenzentrum Heidelberg
Heidelberg, Baden-Württemberg, Germany, 69120
Universitätsklinik Heidelberg - Diagnostische und Interventionelle Radiologie
Heidelberg, Baden-Württemberg, Germany
ze:ro Dialysezentrum Schwetzingen
Schwetzingen, Baden-Württemberg, Germany, 68723
Sponsors and Collaborators
BioPheresis GmbH
Dr. M. Koehler GmbH
ARTIMED Medical Consulting GmbH
Principal Investigator: Juergen Krauss, MD Nationales Centrum für Tumorerkrankungen (NCT)
Study Director: Niels Emmerich, PhD BioPheresis GmbH

Responsible Party: Niels Emmerich, Ph.D., CEO, BioPheresis GmbH Identifier: NCT01013168     History of Changes
Other Study ID Numbers: BP-005
First Posted: November 13, 2009    Key Record Dates
Last Update Posted: July 22, 2011
Last Verified: July 2011

Keywords provided by BioPheresis GmbH:
immune apheresis

Additional relevant MeSH terms: