White Cell Transfer as Cancer Therapy
N/A
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific
Trial Information
White Cell Transfer as Cancer Therapy
OBJECTIVES:
Primary
- Determine the safety of white blood cell infusion in patients with metastatic or
unresectable cancer.
Secondary
- Determine the efficacy of this therapy in these patients.
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed malignancy
- Metastatic or unresectable disease
- Standard curative or palliative measures do not exist or are no longer effective
- 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:
- Bone lesions
- Ascites
- Pleural/pericardial effusion
- Lymphangitis cutis/pulmonis
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
- 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
- Less than 60% CKA allowed if deemed suitable by the investigators
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 4 months
- ANC ≥ 1,000/µL
- Platelet count > 100,000/µL (platelet transfusion independent)
- Serum bilirubin ≤ 2 mg/dL
- AST and ALT < 3 times upper limit of normal
- Serum creatinine ≤ 2 mg/dL
- No uncontrolled diabetes mellitus
- No myocardial infarction within the past 30 days
- No active serious infection
- No HIV infection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Negative panel reactive antibody test (i.e., absence of serum HLA antibody)
PRIOR CONCURRENT THERAPY:
- No prior fludarabine phosphate
- No prior stem cell transplantation
- At least 4 weeks since prior medical therapy, radiotherapy, or surgery
- More than 30 days since prior immunosuppressive agents other than steroids
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Safety
Safety Issue:
Yes
Principal Investigator
Zheng Cui, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Comprehensive Cancer Center of Wake Forest University
Authority:
Unspecified
Study ID:
CCCWFU-99107
NCT ID:
NCT00607802
Start Date:
Completion Date:
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- Unspecified Childhood Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- unspecified childhood solid tumor, protocol specific
- Neoplasms
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