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

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

White Cell Transfer as Cancer Therapy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00607802
• Other study ID #: CCCWFU-99107
• Secondary ID: CDR0000584624IRB
• Status: Withdrawn
• Phase: N/A
• First received: January 30, 2008
• Last updated: January 17, 2017

Study information

• Verified date: June 2013
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Unspecified Adult Solid Tumor, Protocol Specific
• Unspecified Childhood Solid Tumor, Protocol Specific

Intervention

Biological:
• leukocyte therapy

Genetic:
• polymerase chain reaction

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety
Secondary	Response (complete response, partial response, stable disease, or disease progression)