A Phase I/II Study For the Use of White Blood Cells From Healthy Donor-participants To Treat Subjects With Solid Cancers
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-specific donors; these donors will be tested for HLA-specific genotyping as
well as fully tested for infectious diseases.
Each patient will be receiving granulocytes from approximately 4 to 6 donors. Each donor
will be HLA-mismatched to avoid engraftment of the granulocytes and any transfusion-related
GVHD. These infusions will take place over a 1 to 2 week period, the timing of which will
be dependent on both the subject's tolerance and the availability of the donors.
Subject Response Assessment:
For all patients not demonstrating disease progression, response status will be evaluated
between Days +90 to +100 after the last infusion. Day+1 is the first day of white cell
infusion. All measurable lesions (lesions that can be accurately measured in at least one
dimension [longest diameter to be recorded] as ≥20 mm with conventional techniques or as ≥10
mm with spiral CT scan) up to a maximum of 10 lesions representative of all involved organs
should be identified as target lesions and will be recorded and measured at baseline. Target
lesions should be selected on the basis of their size (lesions with the longest diameter)
and their suitability for accurate repetitive measurements (either by imaging techniques or
clinically). A sum of the longest diameter (LD) for all target lesions will be calculated
and reported as the baseline sum LD. The baseline sum LD will be used as reference to
further characterize the objective tumor response of the measurable dimension of the
disease. The criteria for response, progression, and relapse are as follows.
- Complete Response: Disappearance of all target lesions.
- Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD)
of target lesions taking as reference the baseline sum LD.
- Progression (PD): At least a 20% increase in the sum of the LD of target lesions taking
as references the smallest sum LD recorded since the treatment started or the
appearance of one or more new lesions.
- Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient
increase to qualify for PD taking as references the smallest sum LD since the treatment
started. Patients having a documented response with no reconfirmation of the response
will be listed with stable disease.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Dipnarine Maharaj, MD
Medical Director, South Florida Bone Marrow / Stem Cell Transplant Institute
United States: Food and Drug Administration
|South Florida Bone Marrow / Stem Cell Transplant Institute||Boynton Beach, Florida 33437|