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NCT Number: NCT01831505

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

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.

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Key information

Conditions

Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

Primary outcomes

  1. Evaluation of the response to locally injected drugs

    Time frame: 1-3 days post injection after injection

Secondary outcomes

  1. Evaluate the safety profile of multiple simultaneous microinjections using custom syringe

    Time frame: up to 28 days

Sponsors and collaborators

Lead sponsor

Presage Biosciences

Industry

Collaborators

  • Fred Hutchinson Cancer Center
  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 15, 2013
Registry last updated
Feb 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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