Study Using White Blood Cells from Healthy Donors to Treat Solid Cancers
Sponsor: Dipnarine Maharaj
ClinicalTrials ID:NCT00900497
This clinical trial is exploring whether infusions of white blood cells from healthy donors can help treat solid cancers in patients. The study aims to see if these cells can safely and effectively reduce cancer growth.
Patient Parameters
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Program Overview
This study is testing a new cancer treatment using white blood cells from healthy donors to help fight solid tumors. Researchers are interested in whether these cells, which are part of the body's natural defense system, can be used to attack cancer cells in patients. The white blood cells, mainly a type called granulocytes, are collected from donors and given to patients over 1-2 weeks. The study will monitor patients for any side effects and check if the cancer shrinks over three months after treatment.
Description
In this study, up to 29 patients with advanced solid tumors will receive white blood cell infusions from healthy donors. These donors are unrelated and have different genetic markers to avoid complications. The treatment involves receiving cells from 4-6 donors over 1-2 weeks, with one infusion per day. After each infusion, patients will be closely monitored for side effects. The study will track the cancer's response for three months after the last infusion, measuring any changes in tumor size. The main goals are to assess the treatment's safety, how well patients tolerate it, and its effectiveness in reducing cancer.
Eligibility Criteria
Exclusion Criteria
- Uncontrolled diabetes or serious heart disease.
- Active infections or HIV without recent treatment.
- Pregnant or breastfeeding women.
- Men and women of reproductive age not using birth control.
- Positive pregnancy test before treatment.
- Certain antibodies present in the blood.
- History of stem cell transplant.
- Brain tumors or metastases.
- Previous treatment with fludarabine.
For Donors:
- Must be healthy and eligible to donate blood.
- Must agree to donate white blood cells and undergo the collection process.
- Must have a genetic profile that ensures a mismatch with the recipient.
- Must be tested for certain viruses and have compatible blood types with the patient.
Donors cannot:
- Have certain antibodies or positive infectious disease tests.
- Have heart conditions that pose risks during cell collection.
- Be genetically related to the patient.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| South Florida Bone Marrow / Stem Cell Transplant Institute | 33437 | Boynton Beach | Florida |
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