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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Information provided by:
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00607802
First received: January 30, 2008
Last updated: June 4, 2013
Last verified: June 2013
  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

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • Safety [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response (complete response, partial response, stable disease, or disease progression) [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607802

Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Study Chair: Zheng Cui, MD, PhD Comprehensive Cancer Center of Wake Forest University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00607802     History of Changes
Other Study ID Numbers: CCCWFU-99107, CDR0000584624, IRB00002178
Study First Received: January 30, 2008
Last Updated: June 4, 2013
Health Authority: Unspecified

Keywords provided by Comprehensive Cancer Center of Wake Forest University:
unspecified adult solid tumor, protocol specific
unspecified childhood solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on September 15, 2014