Completed

Feasibility of Assessing Lymphoma Response to Precise Local Injection of Candidate Chemotherapy Agents Using the CIVO(tm) Microdosing System

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Multiple drug microinjection: rituximab, vincristine, doxorubicin, bendamustine, prednisolone or a combination of them

Drug
Who is being recruted

Hemic and Lymphatic Diseases+5

+ Immune System Diseases

+ Immunoproliferative Disorders

Over 18 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Phase 1
Interventional
Study Start: November 2012
See protocol details

Summary

Principal SponsorPresage Biosciences
Last updated: February 27, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01831505
Principal SponsorPresage Biosciences
Last updated: February 27, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

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

4 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeLymphoma

Criteria

5 inclusion criteria required to participate
18 years of age or over
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%)
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
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6 exclusion criteria prevent from participating
Any therapy that is potentially immunosuppressive or has anticancer activity in the 4 weeks prior to device microinjection
Inability to give informed consent
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 active fungal, viral, or bacterial infections
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Multiple drug microinjection with locally injected rituximab, vincristine, doxorubicin, bendamustine, prednisolone, or a combination of them

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Seattle Cancer Care Alliance

Seattle, United StatesOpen Seattle Cancer Care Alliance in Google Maps
CompletedOne Study Center