Donor Natural Killer Cells After Donor Stem Cell Transplant in Treating Patients With Advanced Ca… (NCT00823524) | Clinical Trial Compass
CompletedPhase 1/2
Donor Natural Killer Cells After Donor Stem Cell Transplant in Treating Patients With Advanced Cancer
South Korea47 participantsStarted 2009-01
Plain-language summary
RATIONALE: Giving an infusion of natural killer cells from a donor after a donor stem cell transplant may help kill any remaining cancer cells after the transplant.
PURPOSE: This phase I/II trial is studying the side effects and best dose of donor natural killer cells when given after a donor stem cell transplant in treating patients with advanced cancer.
Who can participate
Age range15 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Diagnosis of a malignant disorder (hematologic malignancies or solid tumors)
* Advanced disease
* Has undergone prior allogeneic hematopoietic stem cell transplantation (HSCT) from an HLA-mismatched/haploidentical familial donor
* Progressive or recurrent disease, as defined by any of the following (phase II):
* Peripheral blood blast \> 20% with bone marrow aspirate showing \> 5% leukemic cells (in patients with acute leukemia)
* Detection of metaphases in the marrow with the same clonal cytogenetic abnormalities as identified before HSCT (or by FISH markers, if appropriate) (in patients with acute leukemia or high-risk myelodysplastic syndromes \[MDS\])
* Persistent cytopenia with bone marrow aspirate showing various degrees of dysplasia involving ≥ 1 cell lineage (in patients with high-risk MDS)
* Enlargement of pre-existing measurable lesions by 20% according to RECIST criteria (in patients with solid tumors or lymphoma)
* Appearance of new metastatic lesions, including pleural effusion or ascites, radiologically typical for metastases or confirmed as such by cytology (in patients with solid tumors or lymphoma)
* Measurable disease (phase II)
PATIENT CHARACTERISTICS:
* Karnofsky performance status 70-100%
* Total bilirubin \< 3.0 mg/dL
* AST \< 5 times upper limit of normal
* Creatinine \< 3 mg/dL
* Not pregnant or nursing
* No clinically evident cardiac or pulmonary failure
PRIOR CONCURRENT THERAPY:
* See Disease Characterist…
What they're measuring
1
Safety
Timeframe: 15 days to 1 year after transplantation