Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Robert Lowsky
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).
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Biopsy-confirmed relapsed, refractory, or progressive NHL or HL (Refer to Section 3.2.1 for excluded subtypes)
At least 3 sites of disease
1. One for diagnosis (lymph node or bone marrow biopsy)
2. One palpable for treatment
3. One measurable radiographically
\> 60 days after RIC allogeneic transplant for lymphoma
18 years of age or older
Mixed (5-95%) or complete (\>95%) chimerism
Eastern Oncology Cooperative Group (ECOG) performance status ≤ 2
ANC \>1000/mm3, platelets \>50,000/mm3
Total bilirubin ≤ 2.5 mg/dL, AST and ALT \< 3 times upper limit of normal
Serum creatinine ≤ 3 mg/dL
No chemotherapy, RT, DLI or biologic therapy for lymphoma at least 4 weeks prior to scheduled treatment
Minimal immunosuppression (defined as monotherapy with ≤ 10 mg prednisone daily, ≤ 200 mg cyclosporine daily, or ≤ 2 mg tacrolimus daily) at least 2 weeks prior to scheduled treatment
You may not be if
HIV associated lymphoma
Acute GVHD at time of enrollment (history of treated and resolved GVHD is permitted)
Active infection within 14 days prior to scheduled treatment
Active Cytomegalovirus (CMV) disease at the time of enrollment
Pre-existing autoimmune or antibody mediated disease (including systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, and autoimmune thrombocytopenia)
