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

This study is currently recruiting participants.
Verified April 2013 by Presage Biosciences
Sponsor:
Collaborators:
Fred Hutchinson Cancer Research Center
Information provided by (Responsible Party):
Presage Biosciences
ClinicalTrials.gov Identifier:
NCT01831505
First received: April 8, 2013
Last updated: April 15, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Lymphoma
Drug: Multiple drug microinjection: rituximab, vincristine, doxorubicin and/or prednisolone
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Presage Biosciences:

Primary Outcome Measures:
  • Evaluation of the response to locally injected drugs [ Time Frame: 1-3 days post injection after injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the safety profile of multiple simultaneous microinjections using custom syringe [ Time Frame: up to 28 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: November 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Multiple drug microinjection
Multiple drug microinjection with locally injected rituximab, vincristine, doxorubicin and/or prednisolone
Drug: Multiple drug microinjection: rituximab, vincristine, doxorubicin and/or prednisolone

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01831505

Contacts
Contact: Clinical Trials Coordinator (800) 530-5404 clinicaltrials@presagebio.com

Locations
United States, Washington
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Principal Investigator: Oliver W Press, MD, PhD         
Sponsors and Collaborators
Presage Biosciences
Fred Hutchinson Cancer Research Center
Investigators
Principal Investigator: Oliver W Press, MD, PhD Fred Hutchinson Cancer Research Center
  More Information

No publications provided

Responsible Party: Presage Biosciences
ClinicalTrials.gov Identifier: NCT01831505     History of Changes
Other Study ID Numbers: PRS-1, R42CA144104-02
Study First Received: April 8, 2013
Last Updated: April 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Presage Biosciences:
personalized medicine
in vivo drug sensitivity
chemotherapy
lymphoma
microinjection

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Doxorubicin
Rituximab
Prednisolone
Methylprednisolone Hemisuccinate
Vincristine
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on April 15, 2014