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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
Must not have
Uncontrolled diabetes mellitus, significant cardiac disease, or active serious infection
Men or Women of reproductive age not using effective birth control
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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My cancer is confirmed by tests, cannot be surgically removed, and has spread.
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I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have uncontrolled diabetes, serious heart conditions, or active infections.
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I am of reproductive age and not using effective birth control.
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I have been tested for HLA Class I & II antibodies.
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I have brain tumors or cancer that has spread to my brain.
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I am a woman who can have children and my pregnancy test is positive.
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I have had a stem cell transplant in the past.
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I have been treated with fludarabine before.
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I have HIV and have used drugs that weaken the immune system, not including steroids.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

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

White Blood Cells/Granulocytes (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00900497 — Phase 1 & 2
Solid Tumors Research Study Groups: White Blood Cells/Granulocytes
Solid Tumors Clinical Trial 2023: White Blood Cells/Granulocytes Highlights & Side Effects. Trial Name: NCT00900497 — Phase 1 & 2
White Blood Cells/Granulocytes (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00900497 — Phase 1 & 2
~3 spots leftby Dec 2026
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