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

Not Applicable

Withdrawn

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Unspecified Childhood Solid Tumor, Protocol Specific

• Registration Number: NCT00607802
• Lead Sponsor: Wake Forest University Health Sciences

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 Timeline

• Study First Submitted: 2008-01-30
• Study First Submitted QC: 2008-01-30
• Study First Posted: 2008-02-06
• Status Verified: 2013-06
• Last Update Submitted: 2017-01-17
• Last Update Posted: 2017-01-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety

Secondary Outcome Measures

Name	Time	Method
Response (complete response, partial response, stable disease, or disease progression)