- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00607802
Donor White Blood Cell Infusion in Treating Patients With Metastatic or Unresectable Cancer
White Cell Transfer as Cancer Therapy
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Safety
|
Secondary Outcome Measures
Outcome Measure |
---|
Response (complete response, partial response, stable disease, or disease progression)
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Zheng Cui, MD, PhD, Wake Forest University Health Sciences
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCCWFU-99107
- CDR0000584624 (Registry Identifier: PDQ (Physician Data Query))
- IRB00002178
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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