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

February 24, 2017 updated by: Presage Biosciences

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Presage Biosciences

Collaborators

National Cancer Institute (NCI)
National Institutes of Health (NIH)
Fred Hutchinson Cancer Center

Investigators

  • Principal Investigator: Oliver W Press, MD, PhD, Fred Hutchinson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

April 8, 2013

First Submitted That Met QC Criteria

April 10, 2013

First Posted (Estimate)

April 15, 2013

Study Record Updates

Last Update Posted (Actual)

February 27, 2017

Last Update Submitted That Met QC Criteria

February 24, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRS-1
  • R42CA144104-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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