Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:29 AM
Study NCT ID:
NCT00607802
Status:
WITHDRAWN
Last Update Posted:
2017-01-19
First Post:
2008-01-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Donor White Blood Cell Infusion in Treating Patients With Metastatic or Unresectable Cancer
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
White Cell Transfer as Cancer Therapy
Status:
WITHDRAWN
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: