Feasibility of Assessing Lymphoma Response to Precise Local Injection of Candidate Chemotherapy Agents
Completed · Phase 1
Conditions studied: Lymphoma
In brief
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.
Key facts
- Study ID
- NCT01831505
- Run by
- Presage Biosciences
- People needed
- 4
- Starts
- 2012-11-01
- Expected to finish
- 2013-07-01
- Last updated by the study team
- 2017-02-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Seattle Cancer Care Alliance — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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