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A Phase I/II Study For the Use of White Blood Cells From Healthy Donor-participants To Treat Subjects With Solid Cancers

Phase 1/Phase 2
18 Years
Open (Enrolling by invite only)
Solid (Non-hematological) Malignant Tumors

Thank you

Trial Information

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.

Inclusion Criteria

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

- 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

- 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.

- No uncontrolled diabetes mellitus, significant cardiac disease, e.g. recent
myocardial infarction ≥ within 30 days, or active serious infection.

- No HIV infection and no recent use (within 30 days) of immunosuppressive agents other
than steroids.

- Women should not be pregnant or nursing while participating in this trial. Both men
and women of reproductive potential should agree to use an effective means of birth
control. Women of childbearing potential should have a negative serum pregnancy test
before treatment.

- Negative for HLA Class I & II antibodies.

- Negative neutrophil antibody test.

- No prior history of stem cell transplantation.

- No evidence of brain tumors or metastases.

- No 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

- Must have a negative Neutrophil antibody test

- Must have a negative infectious disease workup within 30 days of apheresis /

- Must not have any known cardiac illness that could cause a potential risk associated
with leukapheresis.

- Must not have a genetic relationship to the recipient

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

90 to 100 days post treatment

Safety Issue:


Principal Investigator

Dipnarine Maharaj, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical Director, South Florida Bone Marrow / Stem Cell Transplant Institute


United States: Food and Drug Administration

Study ID:




Start Date:

April 2009

Completion Date:

December 2013

Related Keywords:

  • Solid (Non-hematological) Malignant Tumors
  • granulocytes
  • Graft-vs-Host-Disease
  • Neoplasms



South Florida Bone Marrow / Stem Cell Transplant InstituteBoynton Beach, Florida  33437