This trial is active, not recruiting.

Condition lymphoma
Treatment multiple drug microinjection: rituximab, vincristine, doxorubicin, bendamustine, prednisolone or a combination of them
Phase phase 1
Sponsor Presage Biosciences
Collaborator National Institutes of Health (NIH)
Start date November 2012
End date November 2015
Trial size 12 participants
Trial identifier NCT01831505, PRS-1, R42CA144104-02


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose basic science
Multiple drug microinjection with locally injected rituximab, vincristine, doxorubicin, bendamustine, prednisolone, or a combination of them
multiple drug microinjection: rituximab, vincristine, doxorubicin, bendamustine, prednisolone or a combination of them

Primary Outcomes

Evaluation of the response to locally injected drugs
time frame: 1-3 days post injection after injection

Secondary Outcomes

Evaluate the safety profile of multiple simultaneous microinjections using custom syringe
time frame: up to 28 days

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Feasibility of Assessing Lymphoma Response to Precise Local Injection of Candidate Chemotherapy Agents Using the CIVO(tm) Microdosing System
Principal investigator Oliver W Press, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Presage Biosciences.