White Blood Cell Infusions for Solid Cancers
Trial Summary
What is the purpose of this trial?
Background \& Rationale: About 75% of US population living today will not die of cancer. There has been a recent report of a colony of cancer-resistant mice developed from a single male mouse that unexpectedly survived challenges of lethal cancer cell injections. In these so-called spontaneous regression/complete resistant (SR/CR) mice, cancer cells are killed by rapid infiltration of leukocytes, mainly of innate immunity. This highly effective natural cancer immunity is inherited and mediated entirely by white blood cells. Moreover, this cancer resistance can be transferred to wild type mice through the transfer of various immune cell types including granulocytes. The infusion of white blood cells, particularly cells of innate immunity, is a viable anticancer therapy in humans as well. This proposed trial will test whether white blood cell infusions from healthy unrelated donors can be used to treat cancer. The trial is designed to determine whether responses can be seen in cancer patients after infusion of HLA-mismatched white cells from healthy donors. It is important that the donors and recipients be unrelated and HLA-mismatched to avoid the possibility of transfusion-related Graft vs. Host Disease. The white blood cells from the healthy donors are being collected via apheresis following granulocyte mobilization with dexamethasone and filgrastim. The investigators will refer to the white blood cells as 'granulocytes' because 75-90% of the white blood cells collected through the apheresis will consist of granulocytes. The dose of at least 2x10 to the11th will be given from 4-5 donors at a rate of no more than one donor per day for each recipient. There will only be one infusion per day and no more than 5 infusions per week. Thus, a typical treatment in the study would span 1-2 weeks. After each infusion, the patients will be monitored carefully for possible adverse events. If adverse events occur at any time point during or after individual infusion, the treatment can be stopped until the adverse events can be managed. The daily dose of each infusion is a frequently used level that has a long safety record. The trial will observe the subject's cancer for 3 months after the granulocyte infusions are completed. Response at 90 days will be based on comparison of tumor measurements at baseline. The trial has 3 major endpoints: dose response and tolerance, safety, and efficacy.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, you must have completed any prior medical therapy, radiation therapy, or surgery at least 4 weeks before joining the trial.
What data supports the effectiveness of the treatment White Blood Cells/Granulocytes for solid cancers?
Research suggests that granulocyte transfusions, which are a type of white blood cell, have shown potential in treating infections in patients with low neutrophil levels (a type of white blood cell important for fighting infections). Additionally, studies indicate that granulocytes may play a role in controlling tumor growth, as seen in experiments with mice, suggesting they could have potential anti-cancer effects.12345
Is white blood cell infusion therapy generally safe for humans?
How does the treatment of White Blood Cell Infusions for Solid Cancers differ from other treatments?
White Blood Cell Infusions, specifically granulocyte transfusions, are unique because they involve directly infusing white blood cells to help fight infections in patients with low white blood cell counts, unlike traditional cancer treatments that primarily target cancer cells. This approach is particularly beneficial for patients with neutropenia (low levels of neutrophils, a type of white blood cell) who are at high risk for infections, offering a supportive therapy to enhance the body's immune response.111121314
Research Team
Dipnarine Maharaj, MD
Principal Investigator
Medical Director, South Florida Bone Marrow / Stem Cell Transplant Institute
Eligibility Criteria
This trial is for people with solid tumors that are metastatic or unresectable, where standard treatments have failed. Participants must be able to donate white blood cells (granulocytes), have a specific HLA mismatch with the donor, and meet certain health criteria like good organ function and performance status. Pregnant women, those with brain tumors or recent serious illnesses, and individuals on recent immunosuppressants cannot join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive granulocyte infusions from healthy donors over a period of 1-2 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, with response assessment between Days +90 to +100
Treatment Details
Interventions
- White Blood Cells/Granulocytes
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dipnarine Maharaj
Lead Sponsor