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
Sponsor:
Collaborators:
Fred Hutchinson Cancer Research Center
Information provided by (Responsible Party):
Presage Biosciences
ClinicalTrials.gov Identifier:
NCT01831505
First received: April 8, 2013
Last updated: July 15, 2014
Last verified: July 2014

April 8, 2013
July 15, 2014
November 2012
November 2015   (final data collection date for primary outcome measure)
Evaluation of the response to locally injected drugs [ Time Frame: 1-3 days post injection after injection ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01831505 on ClinicalTrials.gov Archive Site
Evaluate the safety profile of multiple simultaneous microinjections using custom syringe [ Time Frame: up to 28 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Feasibility of Assessing Lymphoma Response to Precise Local Injection of Candidate Chemotherapy Agents
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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Lymphoma
Drug: Multiple drug microinjection: rituximab, vincristine, doxorubicin, bendamustine, prednisolone or a combination of them
Experimental: Multiple drug microinjection
Multiple drug microinjection with locally injected rituximab, vincristine, doxorubicin, bendamustine, prednisolone, or a combination of them
Intervention: Drug: Multiple drug microinjection: rituximab, vincristine, doxorubicin, bendamustine, prednisolone or a combination of them
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12
November 2015
November 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Clinical Trials Coordinator (800) 530-5404 clinicaltrials@presagebio.com
United States
 
NCT01831505
PRS-1, R42CA144104-02
Yes
Presage Biosciences
Presage Biosciences
  • National Institutes of Health (NIH)
  • National Cancer Institute (NCI)
  • Fred Hutchinson Cancer Research Center
Principal Investigator: Oliver W Press, MD, PhD Fred Hutchinson Cancer Research Center
Presage Biosciences
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP