Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Presage Biosciences
Fred Hutchinson Cancer Research Center
Information provided by (Responsible Party):
Presage Biosciences Identifier:
First received: April 8, 2013
Last updated: July 15, 2014
Last verified: July 2014

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.

Condition Intervention Phase
Drug: Multiple drug microinjection: rituximab, vincristine, doxorubicin, bendamustine, prednisolone or a combination of them
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Feasibility of Assessing Lymphoma Response to Precise Local Injection of Candidate Chemotherapy Agents Using the CIVO(tm) Microdosing System

Resource links provided by NLM:

Further study details as provided by Presage Biosciences:

Primary Outcome Measures:
  • Evaluation of the response to locally injected drugs [ Time Frame: 1-3 days post injection after injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the safety profile of multiple simultaneous microinjections using custom syringe [ Time Frame: up to 28 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: November 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Multiple drug microinjection
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01831505

Contact: Clinical Trials Coordinator (800) 530-5404

United States, Washington
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Principal Investigator: Oliver W Press, MD, PhD         
Sponsors and Collaborators
Presage Biosciences
Fred Hutchinson Cancer Research Center
Principal Investigator: Oliver W Press, MD, PhD Fred Hutchinson Cancer Research Center
  More Information

No publications provided

Responsible Party: Presage Biosciences Identifier: NCT01831505     History of Changes
Other Study ID Numbers: PRS-1, R42CA144104-02
Study First Received: April 8, 2013
Last Updated: July 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Presage Biosciences:
personalized medicine
in vivo drug sensitivity
microinjection processed this record on March 03, 2015