NCT00900497
A Study Using White Blood Cells From Healthy Donors To Treat Solid Cancers
Enrolling by Invitation
PHASE1Ages 18+InterventionalTreatmentDipnarine MaharajInvestigator-initiated
~29 participants
Updated 2026-05-01 on ClinicalTrials.gov
What's tested:White Blood Cells/Granulocytes
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over 90 to 100 days post treatment
Conditions
Where it's being run
1 sites across 1 statesFlorida1
Study leadership
- Dipnarine Maharaj, MD · PRINCIPAL_INVESTIGATOR · Medical Director, South Florida Bone Marrow / Stem Cell Transplant Institute
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Must have signed Subject Informed Consent form
Documentation of Disease: All patients must have histologically or cytologically confirmed non-hematological malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
Measurable Disease: Lesions that can be accurately measured in at least one dimension (longest diameter recorded) as ³20 mm with conventional technique or as ³10 mm with spiral CT scan.
Life expectancy of at least 4 months as judged by the PI at the time of consent
Performance status of ≤2 on the ECOG scale (see Appendix I).
≥ 4 weeks since prior medical therapy, radiation therapy, and surgery
Adequate organ function, such as absolute neutrophils ≥1,500/µl, platelet transfusion independent,
platelet count ≥100,000/µl, serum bilirubin ≤2 mg/dl, AST/ALT less than 3x upper limit of normal and serum creatinine ≤2 mg/dl.
Must have signed Donor-participant Informed Consent Form
Must be a healthy, eligible blood donor who has completed Full-Length Universal Donor History Questionnaire version 1.2
Must be able to donate granulocytes and be willing to undergo granulocyte apheresis
Must have an HLA profile (A, B, DR) with results that ensure donated granulocytes will be mismatched with the recipient
Must have CMV negative or positive sero-testing completed; only seronegative donors are accepted for a seronegative recipient
Must have compatible ABO and RH typing with the subject
Must be negative for HLA Class I \& II antibodies
Exclusion
Uncontrolled diabetes mellitus, significant cardiac disease, e.g. recent myocardial infarction ≥ within 30 days, or active serious infection.
HIV infection and no recent use (within 30 days) of immunosuppressive agents other than steroids.
Pregnant or nursing women.
Men or Women of reproductive age who are not using an effective means of birth control.
Women of childbearing potential who have a positive serum pregnancy test prior to treatment.
HLA Class I \& II antibodies.
Neutrophil antibody test.
Prior history of stem cell transplantation.
Evidence of brain tumors or metastases.
Prior history of fludarabine therapy.
Positive Neutrophil antibody test
Positive infectious disease workup within 30 days of apheresis / donation.
Positive known cardiac illness that could cause a potential risk associated with leukapheresis.
Genetic relationship to the recipient
What this trial 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.90 to 100 days post treatment