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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01831505
• Other study ID #: PRS-1
• Secondary ID: R42CA144104-02
• Status: Completed
• Phase: Phase 1
• First received: April 8, 2013
• Last updated: February 24, 2017
• Start date: November 2012
• Est. completion date: July 2013

Study information

• Verified date: February 2017
• Source: Presage Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma

Intervention

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

Locations

Country	Name	City	State
United States	Seattle Cancer Care Alliance	Seattle	Washington

Sponsors (4)

Lead Sponsor	Collaborator
Presage Biosciences	Fred Hutchinson Cancer Research Center, National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the response to locally injected drugs		1-3 days post injection after injection
Secondary	Evaluate the safety profile of multiple simultaneous microinjections using custom syringe		up to 28 days