Intratumoral Injection of an Immunostimulatory CpG, SD-101, Combined With Local Radiation for the Treatment of Recurrent or Progressive Lymphoma After Allogeneic Hematopoietic Cell Transplantation
Patients will receive low dose radiation to all bulky or symptomatic lymph nodes on days -2
and -1. SD-101 will be administered intratumorally to the single largest palpable node
within 24 hours after completion of radiation, on day 0. Two additional intratumoral SD-101
injections will be performed on days 7 (+/- 2 days) and 14 (+/- 2 days). This is a dose
ranging study using a 3+3 design with a definition of maximum tolerated dose (MTD) which our
group has found acceptable in the past. The first cohort of patients will receive a SD-101
dose of 0.3 mg per injection. The dose will be escalated to 1 mg and 3 mg based on dose
limiting toxicity (DLT).
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determination of the maximum tolerated dose based on dose limiting toxicity defined as any new grade 3-4 toxicity after the first SD-101 administration
60 Days
Yes
United States: Food and Drug Administration
BMT235
NCT01745354
August 2012
Name | Location |
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Stanford University School of Medicine | Stanford, California 94305-5317 |