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

NCT ID: NCT00607802

Last Updated: 2017-01-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific; Unspecified Childhood Solid Tumor, Protocol Specific

Study Design

• Primary Study Purpose: TREATMENT

Interventions

leukocyte therapy

Intervention Type: BIOLOGICAL

polymerase chain reaction

Intervention Type: GENETIC

Eligibility Criteria

Inclusion 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

• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zheng Cui, MD, PhD

Role: STUDY_CHAIR

Wake Forest University Health Sciences

Other Identifiers

CDR0000584624

Identifier Type: REGISTRY

Identifier Source: secondary_id

IRB00002178

Identifier Type: -

Identifier Source: secondary_id

CCCWFU-99107

Identifier Type: -

Identifier Source: org_study_id