Clinical trial · Interventional
Donor White Blood Cell Infusion in Treating Patients With Metastatic or Unresectable Cancer
White Cell Transfer as Cancer Therapy
NCT00607802CI-TRIAL-00025549withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
| Unspecified Childhood Solid Tumor, Protocol Specific | Childhood Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| leukocyte therapy | Biological | — | UNRESOLVED |
| polymerase chain reaction | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Safety
Secondary outcomes (1)
- measure
- Response (complete response, partial response, stable disease, or disease progression)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 120 Years
Show eligibility criteria text
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 steroidsReferences
Publications (0)
Data not yet available
No reference posted for this study.