Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-24 @ 6:29 PM
NCT ID:
NCT01013168
Eligibility 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-)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01013168
Study Brief:
Protocol Section:
NCT01013168