Lymphoma
Conditions
Keywords
personalized medicine, in vivo drug sensitivity, chemotherapy, lymphoma, microinjection
Brief summary
Many cancer patients are prescribed drugs to which their cancer is already resistant - and thus suffer toxicity with no potential for benefit. Previous attempts to assess chemoresistance or sensitivity in vitro have failed. This is a feasibility study in human patients with newly diagnosed or recurrent lymphoma to determine how human cancerous lymph nodes in situ respond to standard of care therapeutics precisely microinjected with the CIVO(tm) microdosing system.
Interventions
DRUGMultiple drug microinjection: rituximab, vincristine, doxorubicin, bendamustine, prednisolone or a combination of them
Sponsors
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Fred Hutchinson Cancer Center
Presage Biosciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or over * Has enlarged lymph node(s) highly suspicious of lymphoma; or has been diagnosed with lymphoma but is untreated; or has persistent recurrent, or progressive lymphoma * At least one enlarged 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%, creatinine \<3.0 mg/dl, total bilirubin \<4.0 mg/dl, SGOT and SGPT less than five times the institutional upper limits of normal.
Exclusion criteria
* Lymphoma patients in which the delay of surgery until the lymph node resection date 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the response to locally injected drugs | 1-3 days post injection after injection |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the safety profile of multiple simultaneous microinjections using custom syringe | up to 28 days |
Countries
United States
Outcome results
None listed