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

NCT01831505 | Completed Phase 1 DMC

• 2 other identifiers: PRS-1R42CA144104-02
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Lymphoma

Keywords

personalized medicine; in vivo drug sensitivity; chemotherapy; lymphoma; microinjection

Outcome Measures

Primary Outcomes (1)

• Evaluation of the response to locally injected drugs

  1-3 days post injection after injection

Secondary Outcomes (1)

• Evaluate the safety profile of multiple simultaneous microinjections using custom syringe

  up to 28 days

Study Arms (1)

Multiple drug microinjection

EXPERIMENTAL

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

Interventions

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

Multiple drug microinjection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Presage Biosciences: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator
• Fred Hutchinson Cancer Center: collaborator

Study Sites (1)

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Lymphoma

Interventions

Vincristine; Doxorubicin; Bendamustine Hydrochloride; Prednisolone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Benzimidazoles; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Officials

• Oliver W Press, MD, PhD

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2013
• First Posted: April 15, 2013
• Study Start: November 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: February 27, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)