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.)
Sponsor:
Collaborators:
Dr. M. Koehler GmbH
ARTIMED Medical Consulting GmbH
Information provided by:
BioPheresis GmbH
ClinicalTrials.gov Identifier:
NCT01013168
First received: November 4, 2009
Last updated: July 21, 2011
Last verified: July 2011
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Study of OncoSorb® in Patients With Advanced Cancer Entities

Resource links provided by NLM:


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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall response defined by RECIST criteria [ Time Frame: 8 week response rate ] [ Designated as safety issue: No ]
  • Quality of life questionaire (as assessed by EORTC QLQ-C30 rev. 3.0) [ Time Frame: 0-6 months ] [ Designated as safety issue: No ]
  • Kinetics of sTNF-R1, sTNF-R2 and sIL-2R α [ Time Frame: receptor levels will be measured on treatment day 4 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01013168

Locations
Germany
Nationales Centrum für Tumorerkrankungen (NCT)
Heidelberg, Baden-Württemberg, Germany, 69120
Nierenzentrum Heidelberg
Heidelberg, Baden-Württemberg, Germany, 69120
St. Josefskrankenhaus
Heidelberg, Baden-Württemberg, Germany, 69115
Dermatologische Onkologie am NCT
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
Investigators
Principal Investigator: Juergen Krauss, MD Nationales Centrum für Tumorerkrankungen (NCT)
Study Director: Niels Emmerich, PhD BioPheresis GmbH
  More Information

Additional Information:
No publications provided

Responsible Party: Niels Emmerich, Ph.D., CEO, BioPheresis GmbH
ClinicalTrials.gov Identifier: NCT01013168     History of Changes
Other Study ID Numbers: BP-005
Study First Received: November 4, 2009
Last Updated: July 21, 2011
Health Authority: Germany: German Institute of Medical Documentation and Information

Keywords provided by BioPheresis GmbH:
OncoSorb
immune apheresis
sTNF-R1
sTNF-R2
sIL-2R
TNF

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on August 26, 2014