Clinical trial · Interventional
Feasibility of Assessing Lymphoma Response to Precise Local Injection of Candidate Chemotherapy Agents
Feasibility of Assessing Lymphoma Response to Precise Local Injection of Candidate Chemotherapy Agents Using the CIVO(tm) Microdosing System
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multiple drug microinjection: rituximab, vincristine, doxorubicin, bendamustine, prednisolone or a combination of them | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Multiple drug microinjection
- description
- Multiple drug microinjection with locally injected rituximab, vincristine, doxorubicin, bendamustine, prednisolone, or a combination of them
- interventionNames
- Drug: Multiple drug microinjection: rituximab, vincristine, doxorubicin, bendamustine, prednisolone or a combination of them
Primary outcomes (1)
- measure
- Evaluation of the response to locally injected drugs
- timeFrame
- 1-3 days post injection after injection
Secondary outcomes (1)
- measure
- Evaluate the safety profile of multiple simultaneous microinjections using custom syringe
- timeFrame
- up to 28 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available