Clinical trial · Interventional
Clinical Study of OncoSorb® in Patients With Advanced Cancer Entities
NCT01013168CI-TRIAL-00005258BP-005terminatedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Achievement of feasibility and safety without achievement of clinical response.
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer Entities | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apheresis using the OncoSorb column | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- OncoSorb® column
- interventionNames
- Procedure: Apheresis using the OncoSorb column
Primary outcomes (1)
- measure
- Occurrence of: possible catheter infection, suitability of citrate/heparin anticoagulation, adverse events/serious adverse events in general
- timeFrame
- 0-6 months
Secondary outcomes (3)
- measure
- Overall response defined by RECIST criteria
- timeFrame
- 8 week response rate
- measure
- Quality of life questionaire (as assessed by EORTC QLQ-C30 rev. 3.0)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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-)
References
Publications (0)
Data not yet available
No reference posted for this study.