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

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Fred Hutchinson Cancer Research Center
Information provided by (Responsible Party):
Presage Biosciences
ClinicalTrials.gov Identifier:
NCT01831505
First received: April 8, 2013
Last updated: February 24, 2017
Last verified: February 2017

April 8, 2013
February 24, 2017
November 2012
July 2013   (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 ]
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 ]
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
Intervention Model: Single Group Assignment
Masking: No masking
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.
 
Completed
4
July 2013
July 2013   (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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01831505
PRS-1
R42CA144104-02 ( US NIH Grant/Contract Award Number )
Yes
Not Provided
No
Not Provided
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
February 2017

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