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

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Multiple drug microinjection: rituximab, vincristine, doxorubicin, bendamustine, prednisolone or a combination of them
Sponsored by
Presage Biosciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Lymphoma focused on measuring personalized medicine, in vivo drug sensitivity, chemotherapy, lymphoma, microinjection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Seattle Cancer Care Alliance

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Multiple drug microinjection

Arm Description

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

Outcomes

Primary Outcome Measures

Evaluation of the response to locally injected drugs

Secondary Outcome Measures

Evaluate the safety profile of multiple simultaneous microinjections using custom syringe

Full Information

First Posted
April 8, 2013
Last Updated
February 24, 2017
Sponsor
Presage Biosciences
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI), Fred Hutchinson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01831505
Brief Title
Feasibility of Assessing Lymphoma Response to Precise Local Injection of Candidate Chemotherapy Agents
Official Title
Feasibility of Assessing Lymphoma Response to Precise Local Injection of Candidate Chemotherapy Agents Using the CIVO(tm) Microdosing System
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Presage Biosciences
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI), Fred Hutchinson Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
personalized medicine, in vivo drug sensitivity, chemotherapy, lymphoma, microinjection

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multiple drug microinjection
Arm Type
Experimental
Arm Description
Multiple drug microinjection with locally injected rituximab, vincristine, doxorubicin, bendamustine, prednisolone, or a combination of them
Intervention Type
Drug
Intervention Name(s)
Multiple drug microinjection: rituximab, vincristine, doxorubicin, bendamustine, prednisolone or a combination of them
Primary Outcome Measure Information:
Title
Evaluation of the response to locally injected drugs
Time Frame
1-3 days post injection after injection
Secondary Outcome Measure Information:
Title
Evaluate the safety profile of multiple simultaneous microinjections using custom syringe
Time Frame
up to 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver W Press, MD, PhD
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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