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

NCT00607802 | Withdrawn

• 3 other identifiers: CCCWFU-99107CDR0000584624IRB00002178
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

unspecified adult solid tumor, protocol specific; unspecified childhood solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• Safety

Secondary Outcomes (1)

• Response (complete response, partial response, stable disease, or disease progression)

Interventions

leukocyte therapy BIOLOGICAL

polymerase chain reaction GENETIC

Eligibility Criteria

• Age: Up to 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

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

MeSH Terms

Interventions

Polymerase Chain Reaction

Intervention Hierarchy (Ancestors)

Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques

Study Officials

• Zheng Cui, MD, PhD

  Wake Forest University Health Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2008
• First Posted: February 6, 2008
• Last Updated: January 19, 2017

Record last verified: 2013-06