Feasibility of Assessing Lymphoma Response to Precise Local Injection of Candidate Chemotherapy Agents
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01831505|
Recruitment Status : Completed
First Posted : April 15, 2013
Last Update Posted : February 27, 2017
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: Multiple drug microinjection: rituximab, vincristine, doxorubicin, bendamustine, prednisolone or a combination of them||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Feasibility of Assessing Lymphoma Response to Precise Local Injection of Candidate Chemotherapy Agents Using the CIVO(tm) Microdosing System|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
Experimental: Multiple drug microinjection
Multiple drug microinjection with locally injected rituximab, vincristine, doxorubicin, bendamustine, prednisolone, or a combination of them
Drug: Multiple drug microinjection: rituximab, vincristine, doxorubicin, bendamustine, prednisolone or a combination of them
- Evaluation of the response to locally injected drugs [ Time Frame: 1-3 days post injection after injection ]
- Evaluate the safety profile of multiple simultaneous microinjections using custom syringe [ Time Frame: up to 28 days ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01831505
|United States, Washington|
|Seattle Cancer Care Alliance|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Oliver W Press, MD, PhD||Fred Hutchinson Cancer Center|
|Responsible Party:||Presage Biosciences|
|Other Study ID Numbers:||
R42CA144104-02 ( U.S. NIH Grant/Contract )
|First Posted:||April 15, 2013 Key Record Dates|
|Last Update Posted:||February 27, 2017|
|Last Verified:||February 2017|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
in vivo drug sensitivity
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents, Immunological
Physiological Effects of Drugs
Topoisomerase II Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Hormones, Hormone Substitutes, and Hormone Antagonists