Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Can healthy donor cells shrink tumors? new trial aims to find out

NCT ID NCT00900497

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 29 people

The number the study aims to enrol. It can still change while the study runs.

Start date

Apr 2009

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Metastatic non-hematological malignancy are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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.

    Open the record ↗

  3. 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

  • South Florida Bone Marrow / Stem Cell Transplant Institute

    Boynton Beach, Florida, 33437, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.