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

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT00607802
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Unspecified Adult Solid Tumor, Protocol Specific; Unspecified Childhood Solid Tumor, Protocol Specific	Biological: leukocyte therapy; Genetic: polymerase chain reaction	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Primary Purpose: Treatment
• Official Title: White Cell Transfer as Cancer Therapy

Outcome Measures

Primary Outcome Measures

1. Safety []

Secondary Outcome Measures

1. Response (complete response, partial response, stable disease, or disease progression) []

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Wake Forest University Health Sciences
• National Cancer Institute (NCI)

Investigators

• Study Chair: Zheng Cui, MD, PhD, Wake Forest University Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT00607802
• Other Study ID Numbers: CCCWFU-99107; CDR0000584624; IRB00002178
• First Posted: Feb 6, 2008
• Last Update Posted: Jan 19, 2017
• Last Verified: Jun 1, 2013

• Keywords provided by Wake Forest University Health Sciences: unspecified adult solid tumor, protocol specific; unspecified childhood solid tumor, protocol specific
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Jan 19, 2017