Can healthy donor cells shrink tumors? new trial aims to find out
NCT ID NCT00900497
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This trial tests whether infusions of white blood cells from healthy, unrelated donors can help treat solid cancers that have not responded to standard treatments. About 29 patients will receive daily infusions over 1-2 weeks, and their tumors will be checked after 3 months. The study focuses on safety, tolerance, and whether the tumors shrink.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- white blood cells (granulocytes) from healthy donors
- What this could lead to
- If it works, this could point toward a new way to treat solid cancers using donor immune cells.
- What could go wrong
- This is an early phase 1/2 trial with only 29 participants, so results may not apply widely. There are risks of adverse reactions from the infusions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 29 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
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Apr 2009
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria for Subjects: * 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. Exclusion criteria: * 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. Inclusion Criteria for Granulocyte Donors: * 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 criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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South Florida Bone Marrow / Stem Cell Transplant Institute
Boynton Beach, Florida, 33437, United States
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Other studies related to the condition(s) this trial covers.
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- Can a Two-Drug combo outsmart Treatment-Resistant breast cancer?
- Radioactive antibody aims to light up hidden solid tumors
- Experimental biological therapy VRT106 put to the test in advanced solid tumors