Irradiated Donor Lymphocyte Infusion in Treating Patients With Relapsed or Refractory Hematologic Cancer or Solid Tumor
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Irradiated HLA-Partially Matched Allogeneic Related Donor Lymphocytes for Patients With Selected Malignancies|
- Toxicity [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
- Response [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- Presence of disease or antigen-specific lymphocytes [ Time Frame: 10 years ] [ Designated as safety issue: No ]
|Study Start Date:||May 2001|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Biological/Vaccine: therapeutic allogeneic lymphocytes The total CD3+ cell dose target is 1.8 x 108 CD3+ cells/kg +/- 1.0 x 108 CD3+ cells/kg. Up to 6 cycles.
Biological: therapeutic allogeneic lymphocytes
The total CD3+ cell dose target is 1.8 x 108 CD3+ cells/kg +/- 1.0 x 108 CD3+ cells/kg. Up to 6 cycles.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00161187
|United States, New Jersey|
|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School|
|New Brunswick, New Jersey, United States, 08903|
|Principal Investigator:||Roger Strair, MD, PhD||Rutgers Cancer Institute of New Jersey|