Donor White Blood Cell Infusion in Treating Patients With Metastatic or Unresectable Cancer - Full Text View

Sponsors and Collaborators:	Wake Forest University National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00607802

Purpose

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	Intervention
Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific	Biological: leukocyte therapy Genetic: polymerase chain reaction

Study Type:	Interventional
Study Design:	Treatment
Official Title:	White Cell Transfer as Cancer Therapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Safety [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Response (complete response, partial response, stable disease, or disease progression) [ Designated as safety issue: No ]

Estimated Enrollment:	22
Study Start Date:	June 2008
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607802

Sponsors and Collaborators

Wake Forest University

National Cancer Institute (NCI)

Investigators

Study Chair:

Zheng Cui, MD, PhD

Wake Forest University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000584624, CCCWFU-99107, IRB00002178
Study First Received:	January 30, 2008
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00607802 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

ClinicalTrials.gov processed this record on September 03, 2009