Blood Purification Procedure for Pancreatic Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new blood purification procedure to determine its safety and effectiveness for individuals with advanced forms of cancer, specifically metastatic pancreatic or colorectal cancer unresponsive to standard treatments. The treatment employs a device called ONCObind (Onco-Seraph 100 Filter) to filter the blood and reduce harmful substances. Participants may qualify if they have metastatic pancreatic or colorectal cancer resistant to chemotherapy and can provide blood samples for the study.
As an unphased trial, this study offers patients access to innovative treatment options not yet widely available.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that participants should not be in another investigational drug study or have received investigational treatment within 14 days before starting this trial.
What prior data suggests that this blood purification procedure is safe for pancreatic cancer patients?
Research has shown that the ONCObind (Onco-Seraph) 100 Filter has been used in earlier studies without major safety concerns. In one study, five patients with pancreatic cancer underwent the ONCObind procedure, and no safety issues emerged. This suggests that the treatment is generally safe for people.
The ONCObind Filter is a single-use device that cleans the blood outside the body to reduce harmful substances. While early results are promising, further research is needed to fully understand its safety. Those considering this treatment should review these findings and consult their doctor.12345Why are researchers excited about this trial?
Unlike the standard treatments for pancreatic cancer, which often involve chemotherapy or targeted therapies, the ONCObind 100 Filter offers a unique approach by acting as a blood purification device. Researchers are excited about this treatment because it employs an extracorporeal hemoperfusion method, using ultra-high molecular weight polyethylene beads with heparin to potentially remove harmful pathogens and cancer-related particles from the bloodstream. This innovative mechanism could offer a new way to manage pancreatic cancer, providing benefits that current treatments do not address, and possibly improving patient outcomes by directly targeting the blood.
What evidence suggests that this blood purification procedure is effective for pancreatic cancer?
Research has shown that the ONCObind (Onco-Seraph) 100 Filter, which participants in this trial may receive, may help stabilize advanced pancreatic cancer. In some patients, using this device to filter blood has prevented the cancer from worsening. Medical scans in studies have confirmed that the disease remained stable. The ONCObind Filter removes cancer cells from the blood, potentially slowing the cancer's progression. These early results suggest that this treatment could be useful for managing cancers that no longer respond to standard treatments.23678
Who Is on the Research Team?
Lakhmir Chawla, M.D.
Principal Investigator
ExThera Medical
Are You a Good Fit for This Trial?
Adults over 18 with advanced pancreatic cancer or colorectal cancer that's not responding to treatment. They must have a certain number of tumor cells in their blood and be able to perform daily activities with minimal assistance (ECOG PS ≤2).Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction Phase
Participants undergo the ONCObind procedure up to 3-5 times in the first week, followed by 1-3 treatments through week 4
Procedure Follow-up Phase
Participants receive follow-up visits weekly through day 28, then monthly through day 60
Long-term Follow-up
Participants are monitored for safety and effectiveness, with survival follow-up assessed at 60, 120, 180, and 210 days
What Are the Treatments Tested in This Trial?
Interventions
- ONCObind (Onco-Seraph) 100 Filter
Trial Overview
The trial is testing ONCObind, a new procedure for filtering out tumor cells from the blood. Participants will be divided into two groups based on their type of cancer, but there won't be any comparison group receiving a placebo.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
The ONCObind Filter is a single use, disposable column packed with ultra-high molecular weight polyethylene beads which have been modified to contain endpoint attached heparin on the surface. The devices are sterilized using a standard ethylene oxide cycle, following ISO 11135-1:2007. Chemical Indicator labels are located near the product label. ONCObind is part of the Seraph platform technology that was also developed as an extracorporeal broad-spectrum sorbent hemoperfusion device for reduction of pathogens from the bloodstream.
Study patients will be assigned to receive procedure with the investigational device (ONCObind) and will be matched with 60 site specific controls, 30 PDAC and 30 CRC.
Find a Clinic Near You
Who Is Running the Clinical Trial?
ExThera Medical Corporation
Lead Sponsor
Citations
Extracorporeal blood filtration leading to tumor growth ...
Our patient demonstrated significant clinical improvement with scans demonstrating stable disease. Keywords: extracorporeal blood filtration, ...
OSCAR II STUDY - The ONCObind CTC Removal Study
This study is a Prospective Single Arm, dual cohort Open Label Feasibility trial to evaluate the initial safety and signal of efficacy of a novel ...
OSCAR I STUDY - The ONCObind CTC Removal Study
This study is a Prospective Single Arm Open Label Feasibility trial to evaluate the initial safety and signal of efficacy of a novel extracorporeal blood ...
4.
oncotarget.com
oncotarget.com/news/pr/blood-filtration-stabilizes-advanced-pancreatic-cancer-a-case-report/Blood Filtration Stabilizes Advanced Pancreatic Cancer
This is the first documented case of stable disease and reduced symptoms following CTC filtration in advanced pancreatic cancer.
ONCObind™ Extracorporeal Procedure for Metastatic Cancer
The ONCObind Procedure Hemoperfusion Filter is designed for the adsorption of circulating tumor cells (CTCs) from blood.
OSCAR II STUDY - The ONCObind CTC Removal Study
This study is a Prospective Single Arm, dual cohort Open Label Feasibility trial to evaluate the initial safety and signal of efficacy of a novel ...
OSCAR I STUDY - The ONCObind CTC Removal Study - NCI
This study is a Prospective Single Arm Open Label Feasibility trial to evaluate the initial safety and signal of efficacy of a novel extracorporeal blood ...
ExThera Announces Completion of Phase I OSCAR I Trial
A total of five patients with PDAC have completed the ONCObind Procedure with no safety concerns or signals that have been observed. Data has ...
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