Status:
COMPLETED
Feasibility of Assessing Lymphoma Response to Precise Local Injection of Candidate Chemotherapy Agents
Lead Sponsor:
Presage Biosciences
Collaborating Sponsors:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 sensitivit...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01831505
Start Date
November 1 2012
End Date
July 1 2013
Last Update
February 27 2017
Active Locations (1)
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1
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109