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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00607802
First Posted: February 6, 2008
Last Update Posted: January 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences
  Purpose

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.


Condition Intervention
Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific Biological: leukocyte therapy Genetic: polymerase chain reaction

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: White Cell Transfer as Cancer Therapy

Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • Safety

Secondary Outcome Measures:
  • Response (complete response, partial response, stable disease, or disease progression)

Enrollment: 0
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 120 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00607802


Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
Study Chair: Zheng Cui, MD, PhD Wake Forest University Health Sciences
  More Information

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00607802     History of Changes
Other Study ID Numbers: CCCWFU-99107
CDR0000584624 ( Registry Identifier: PDQ (Physician Data Query) )
IRB00002178
First Submitted: January 30, 2008
First Posted: February 6, 2008
Last Update Posted: January 19, 2017
Last Verified: June 2013

Keywords provided by Wake Forest University Health Sciences:
unspecified adult solid tumor, protocol specific
unspecified childhood solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasms