Hemopurifier Plus Pembrolizumab in Head and Neck Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
Summary
- Conditions
- Squamous Cell Carcinoma of the Head and Neck
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: This trial will evaluate the use of the Hemopurifier in combination with pembrolizumab (Keytruda) in patients with advanced and/or metastatic head and neck cancer. The Hemopurifier is a blood filtration device similar to a kidney dialysis cartridge which is designed to remove small particles called exosomes from the blood. Exosomes are believed to be involved in suppression of the immune system in cancer patients. The study will evaluate whether pretreatment with the Hemopurifier before administration of pembrolizumab is safe and well tolerated and results in lower numbers of exosomes in the blood.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
All 12 patients enrolled into this Early Feasibility Phase I clinical trial will receive the same treatment of Hemopurifier plus Pembrolizumab (i.e., 2 rounds of Hemopurifier plus Pembrolizumab followed by Pembrolizumab only up to 2 years). Prior to initiation of the Hemopurifier treatment on Day 1,...
All 12 patients enrolled into this Early Feasibility Phase I clinical trial will receive the same treatment of Hemopurifier plus Pembrolizumab (i.e., 2 rounds of Hemopurifier plus Pembrolizumab followed by Pembrolizumab only up to 2 years). Prior to initiation of the Hemopurifier treatment on Day 1, each subject will undergo phlebotomy to provide a baseline EDTA anti-coagulated blood sample, 30ml (< 3 tablespoons of blood) for the assessments of total exosome protein (TEP) levels and exosome profiles. The kinetics of exosome depletion will be evaluated in the study participants using serial blood samples (5ml) collected hourly during the 4h-depletion period by the Hemopurifier on Day 1. In addition, to evaluate kinetics of exosome recovery, 30ml of blood will be collected just prior to Pembrolizumab infusion (day 1) and on days 7 and 14 after Hemopurifier plus Pembrolizumab treatment during cycle 1 and 2. Exosome recovery after Hemopurifier + Pembrolizumab therapy will be evaluated and used to determine the rate of TEP recovery for each patient. Serial monitoring of TEP during Hemopurifier treatment (hourly during the 4h-depletion period), before Pembrolizumab infusion and after the second round of Pembrolizumab (days 7, and 14) will be done as for the first treatment. Only 2 Hemopurifier treatments will be given. For third and later rounds of Pembrolizumab, the investigators will continue to draw 30mL blood prior to Pembrolizumab infusion for the assessments of TEP levels and exosome profiles.
Tracking Information
- NCT #
- NCT04453046
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Dan Zandberg, MD UPMC Hillman Cancer Center
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