Feasibility of Assessing Lymphoma Response to Precise Local Injection of Candidate Chemotherapy Agents
| Status: | Completed |
|---|---|
| Conditions: | Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/11/2015 |
| Start Date: | November 2012 |
| End Date: | November 2015 |
| Contact: | Clinical Trials Coordinator |
| Email: | clinicaltrials@presagebio.com |
| Phone: | (800) 530-5404 |
Feasibility of Assessing Lymphoma Response to Precise Local Injection of Candidate Chemotherapy Agents Using the CIVO(tm) Microdosing System
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.
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.
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.
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