Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Biomarker/Laboratory analysis, Treatment Approved-not yet active Not specified NCI CCCWFU-99107 CCCWFU 99107, IRB00002178, NCT00607802

Objectives

Primary

1. Determine the safety of white blood cell infusion in patients with metastatic or unresectable cancer.

Secondary

1. Determine the efficacy of this therapy in these patients.

Entry 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

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

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)

Expected Enrollment

Outcomes

Safety

Response (complete response, partial response, stable disease, or disease progression)

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.

Trial Contact Information

Trial Lead Organizations

Wake Forest University Comprehensive Cancer Center

Zheng Cui, MD, PhD, Protocol chair		Ph: 336-716-6185; 800-446-2255

Registry Information
Official Title		White Cell Transfer as Cancer Therapy
Trial Start Date		2008-06-01 (estimated)
Trial Completion Date		2010-09-01 (estimated)
Registered in ClinicalTrials.gov		NCT00607802
Date Submitted to PDQ		2008-01-10
Information Last Verified		2008-03-30
NCI Grant/Contract Number		CA12197

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