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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000584624 | Registry Identifier | PDQ (Physician Data Query) | |
| IRB00002178 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: White blood cells from donors may be able to kill cancer cells in patients with cancer.
PURPOSE: This clinical trial is studying the side effects of donor white blood cell infusion in treating patients with metastatic or unresectable cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive allogeneic white blood cell infusions once daily for 5-10 infusions.
Patients undergo blood sample collection periodically for correlative laboratory studies. The samples are evaluated by in vitro white cell kill assay before the first infusion, immediately after the first infusion, on day 2, and then immediately after the last infusion to assess in vitro cancer cell killing activity. Chimerism studies are performed before the first infusion, immediately after the first infusion, and then on days 2 and 7. Complete chimerism is assayed by short tandem repeat analysis using PCR. Patients with readily accessible tumor tissue (e.g., cervical or axillary lymph nodes or subcutaneous tumor nodules) may also undergo biopsy during the first week of treatment to demonstrate the presence or absence of tumor infiltrating granulocytes.
After completion of study therapy, patients are followed periodically for 3 months.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| leukocyte therapy | Biological | |||
| polymerase chain reaction | Genetic |
| Measure | Description | Time Frame |
|---|---|---|
| Safety |
| Measure | Description | Time Frame |
|---|---|---|
| Response (complete response, partial response, stable disease, or disease progression) |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed malignancy
Measurable or non-measurable disease
Measurable disease is defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
Non-measurable disease is defined as all other lesions (including small lesions and truly non-measurable lesions), including any of the following:
No brain metastasis
Healthy blood donor available meeting the following criteria:
Willing to be included in the White Cell Donor Registry created for this study
Willing to undergo granulocyte apheresis at the American Red Cross
ABO compatible with the patient
HLA-mismatched with the patient
Demonstrates ≥ 60% cytotoxic killing activity (CKA) as determined by in vitro white cell kill assay
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Zheng Cui, MD, PhD | Wake Forest University Health Sciences | Study Chair |
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| ID | Term |
|---|---|
| D016133 | Polymerase Chain Reaction |
| ID | Term |
|---|---|
| D021141 | Nucleic Acid Amplification Techniques |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
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