Know Cancer

or
forgot password

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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

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


Inclusion Criteria:



- 18 years of age or over

- Newly diagnosed lymphoma that would typically be treated with agents in the R-CHOP
regimen OR recurrent/progressive lymphoma in patients who were previously treated
with at least one drug in the R-CHOP regimen or bendamustine.

- At least one cancerous 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%, and coagulation, liver and renal function tests within
normal limits.

Exclusion Criteria:

- Lymphoma patients in which the delay of up to 3 days to surgery 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Evaluation of the response to locally injected drugs

Outcome Time Frame:

1-3 days post injection after injection

Safety Issue:

No

Principal Investigator

Oliver W Press, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Food and Drug Administration

Study ID:

PRS-1

NCT ID:

NCT01831505

Start Date:

November 2012

Completion Date:

May 2014

Related Keywords:

  • Lymphoma
  • personalized medicine
  • in vivo drug sensitivity
  • chemotherapy
  • lymphoma
  • microinjection
  • Lymphoma

Name

Location

Seattle Cancer Care AllianceSeattle, Washington  98109