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

This study has been terminated.
(Achievement of feasibility and safety without achievement of clinical response.)
Dr. M. Koehler GmbH
ARTIMED Medical Consulting GmbH
Information provided by:
BioPheresis GmbH Identifier:
First received: November 4, 2009
Last updated: July 21, 2011
Last verified: July 2011
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 Intervention Phase
Advanced Cancer Entities Procedure: Apheresis using the OncoSorb column Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Study of OncoSorb® in Patients With Advanced Cancer Entities

Further study details as provided by BioPheresis GmbH:

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

Enrollment: 4
Study Start Date: August 2009
Study Completion Date: February 2011
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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-)
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Additional Information:
Responsible Party: Niels Emmerich, Ph.D., CEO, BioPheresis GmbH Identifier: NCT01013168     History of Changes
Other Study ID Numbers: BP-005
Study First Received: November 4, 2009
Last Updated: July 21, 2011

Keywords provided by BioPheresis GmbH:
immune apheresis

Additional relevant MeSH terms:
Neoplasms processed this record on July 25, 2017