Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT00607802
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
120 Years
Study:
NCT00607802
Study Brief:
Protocol Section:
NCT00607802