Status:
ENROLLING_BY_INVITATION
A Study Using White Blood Cells From Healthy Donors To Treat Solid Cancers
Lead Sponsor:
Dipnarine Maharaj
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Background \& Rationale: About 75% of US population living today will not die of cancer. There has been a recent report of a colony of cancer-resistant mice developed from a single male mouse that un...
Detailed Description
Up to 29 Subjects with metastatic, non-hematological cancer can be entered. Potentially hundreds of healthy Donor-participants will be recruited. A Donor Registry will be built to store ABO/Rh-specifi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00900497
Start Date
April 1 2009
End Date
December 1 2027
Last Update
December 4 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
South Florida Bone Marrow / Stem Cell Transplant Institute
Boynton Beach, Florida, United States, 33437