Donor White Blood Cell Infusion in Treating Patients With Metastatic or Unresectable Cancer

Study Overview
=================
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 treating patients with metastatic or unresectable cancer.

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.

Official Title
-----------------
White Cell Transfer as Cancer Therapy

Conditions
-----------------
Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific

Intervention / Treatment
-----------------
* Biological: leukocyte therapy
* Genetic: polymerase chain reaction


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Maximum Age: 120 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: leukocyte therapy|nan|
|Genetic: polymerase chain reaction|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response (complete response, partial response, stable disease, or disease progression) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
unspecified adult solid tumor, protocol specific, unspecified childhood solid tumor, protocol specific