Cancer Clinical Trial
Official title:
A Pilot Study of Irradiated HLA-Partially Matched Allogeneic Related Donor Lymphocytes for Patients With Selected Malignancies
RATIONALE: When irradiated lymphocytes from a donor are infused into the patient they may
help the patient's immune system kill cancer cells.
PURPOSE: This pilot study is looking at the side effects and how well irradiated donor
lymphocyte infusion works in treating patients with relapsed or refractory hematologic
cancer or solid tumor.
OBJECTIVES:
- Determine the toxicity of irradiated allogeneic donor lymphocyte infusion in patients
with relapsed or refractory hematological cancer or solid tumor.
- Determine the response in patients treated with this regimen.
- Determine the presence of disease or antigen-specific lymphocytes in patients treated
with this regimen.
OUTLINE: This is a pilot, open-label, controlled study.
Patients undergo irradiated allogeneic donor lymphocyte infusion over 1 hour on day 1.
Treatment repeats every 8-16 weeks for up to 6 infusions in the absence of disease
progression or unacceptable toxicity.
Blood samples are collected periodically and analyzed for lymphocytotoxicity directed
towards patients' cells (normal and malignant cells) and for disease or antigen-specific
cells. Samples are also analyzed for survival of donor lymphocytes by chimerism studies.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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