Feasibility of Assessing Lymphoma Response to Precise Local Injection of Candidate Chemotherapy Agents

Study Overview
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Brief Summary
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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.

Official Title
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Feasibility of Assessing Lymphoma Response to Precise Local Injection of Candidate Chemotherapy Agents Using the CIVO(tm) Microdosing System

Conditions
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Lymphoma

Intervention / Treatment
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* Drug: Multiple drug microinjection: rituximab, vincristine, doxorubicin, bendamustine, prednisolone or a combination of them


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multiple drug microinjection<br>Multiple drug microinjection with locally injected rituximab, vincristine, doxorubicin, bendamustine, prednisolone, or a combination of them | Drug: Multiple drug microinjection: rituximab, vincristine, doxorubicin, bendamustine, prednisolone or a combination of them<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the response to locally injected drugs |  | 1-3 days post injection after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety profile of multiple simultaneous microinjections using custom syringe |  | up to 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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personalized medicine, in vivo drug sensitivity, chemotherapy, lymphoma, microinjection