Status:
WITHDRAWN
Donor White Blood Cell Infusion in Treating Patients With Metastatic or Unresectable Cancer
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Unspecified Childhood Solid Tumor, Protocol Specific
Eligibility:
All Genders
Up to 120 years
Phase:
NA
Brief Summary
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 trea...
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. O...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00607802
Last Update
January 19 2017
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