Trials / Withdrawn
WithdrawnNCT00607802
Donor White Blood Cell Infusion in Treating Patients With Metastatic or Unresectable Cancer
White Cell Transfer as Cancer Therapy
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Wake Forest University Health Sciences · Academic / Other
- Sex
- All
- Age
- 120 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Unspecified Childhood Solid Tumor, Protocol Specific
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | leukocyte therapy | |
| GENETIC | polymerase chain reaction |
Timeline
- First posted
- 2008-02-06
- Last updated
- 2017-01-19
Source: ClinicalTrials.gov record NCT00607802. Inclusion in this directory is not an endorsement.