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Cell Therapy
White Blood Cell Infusions for Solid Cancers
Phase 1 & 2
Waitlist Available
Led By Dipnarine Maharaj, MD
Research Sponsored by Dipnarine Maharaj
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects must have histologically or cytologically confirmed non-hematological malignancy that is metastatic or unresectable
Performance status of ≤2 on the ECOG scale
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 to 100 days post treatment
Awards & highlights
Study Summary
This trial will test whether white blood cell infusions from healthy unrelated donors can be used to treat cancer.
Who is the study for?
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.Check my eligibility
What is being tested?
The study tests if infusing granulocytes from healthy donors can treat cancer. Patients will receive these white blood cells through a process called apheresis after the donors take medications to increase cell production. The treatment spans 1-2 weeks with daily monitoring for side effects, assessing dose response, safety, and effectiveness over three months.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as fever or chills during infusion. There's also a risk of Graft vs Host Disease due to HLA mismatches but this is minimized by using unrelated donors.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is confirmed by tests, cannot be surgically removed, and has spread.
Select...
I can take care of myself but might not be able to do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 to 100 days post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 to 100 days post treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The trial will observe the subject's cancer status for 3 months after the granulocyte infusions are completed. Response at 90 days will be based on comparison of tumor measurements at baseline.
Secondary outcome measures
The trial will evaluate the safety and dose tolerance of the transfusion of non-irradiated granulocytes (approximately 4 to 6 donors to reach a level of 2 x 10 to the 11th cells) from HLA-mismatched donors
Trial Design
1Treatment groups
Experimental Treatment
Group I: White Blood Cells/GranulocytesExperimental Treatment1 Intervention
Fresh, non-irradiated granulocytes from ABO-Rh compatible, HLA-mismatched donors
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Dipnarine MaharajLead Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled
Dipnarine Maharaj, MDPrincipal InvestigatorMedical Director, South Florida Bone Marrow / Stem Cell Transplant Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is confirmed by tests, cannot be surgically removed, and has spread.I do not have uncontrolled diabetes, serious heart conditions, or active infections.I am of reproductive age and not using effective birth control.I have been tested for HLA Class I & II antibodies.I have brain tumors or cancer that has spread to my brain.I am a woman who can have children and my pregnancy test is positive.I have had a stem cell transplant in the past.I have been treated with fludarabine before.It has been over 4 weeks since my last medical treatment, radiation, or surgery.I can take care of myself but might not be able to do heavy physical work.My organs are functioning well.I have HIV and have used drugs that weaken the immune system, not including steroids.
Research Study Groups:
This trial has the following groups:- Group 1: White Blood Cells/Granulocytes
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research endeavor currently have an open call for participants?
"This research study is not presently looking for participants, as indicated on clinicaltrials.gov which was last updated on May 5th 2022; however, there are 450 other trials searching for candidates at this time. Initially posted April 1st 2009, this trial has since concluded its recruitment process."
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