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

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.
 
ClinicalTrials.gov Identifier: NCT00607802
Recruitment Status : Withdrawn
First Posted : February 6, 2008
Last Update Posted : January 19, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Tracking Information
First Submitted Date  ICMJE January 30, 2008
First Posted Date  ICMJE February 6, 2008
Last Update Posted Date January 19, 2017
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2008)
Safety
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2008)
Response (complete response, partial response, stable disease, or disease progression)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Donor White Blood Cell Infusion in Treating Patients With Metastatic or Unresectable Cancer
Official Title  ICMJE White Cell Transfer as Cancer Therapy
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Unspecified Childhood Solid Tumor, Protocol Specific
Intervention  ICMJE
  • Biological: leukocyte therapy
  • Genetic: polymerase chain reaction
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 4, 2013)
0
Original Enrollment  ICMJE
 (submitted: January 30, 2008)
22
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 120 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00607802
Other Study ID Numbers  ICMJE CCCWFU-99107
CDR0000584624 ( Registry Identifier: PDQ (Physician Data Query) )
IRB00002178
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wake Forest University Health Sciences
Study Sponsor  ICMJE Wake Forest University Health Sciences
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Zheng Cui, MD, PhD Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP