Feasibility of Assessing Lymphoma Response to Precise Local Injection of Candidate Chemotherapy Agents Using the CIVO(tm) Microdosing System
- 18 years of age or over
- Newly diagnosed lymphoma that would typically be treated with agents in the R-CHOP
regimen OR recurrent/progressive lymphoma in patients who were previously treated
with at least one drug in the R-CHOP regimen or bendamustine.
- At least one cancerous lymph node that is considered accessible for percutaneous
injection by the investigator and that is at least 2 cm in longest dimension.
- ECOG performance status of 0-2 (or a Karnofsky performance status of >50%).
- Labs required for enrollment: Absolute neutrophil count > 1000/mm3, platelet count >
50,000/mm3, hematocrit > 25%, and coagulation, liver and renal function tests within
- Lymphoma patients in which the delay of up to 3 days to surgery or other factors
associated with the study are not feasible.
- Patients with central nervous system disease.
- Any therapy that is potentially immunosuppressive or has anticancer activity in the 4
weeks prior to device microinjection.
- Patients with active fungal, viral, or bacterial infections
- Pregnant women.
- Inability to give informed consent.