Clinical Trials Directory

Trials / Terminated

TerminatedNCT03432741

Direct Tumor Microinjection and FDG-PET in Testing Drug Sensitivity in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer

Pilot Safety and Feasibility Study of an In Vivo Sensitivity Screen Using a Direct Tumor Microinjection Technique and FDG-PET

Status
Terminated
Phase
Phase 1
Study type
Interventional
Enrollment
17 (actual)
Sponsor
Mayo Clinic · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This pilot phase I trial studies the side effects of direct tumor microinjection and fludeoxyglucose F-18 positron emission tomography (FDG-PET) in testing drug sensitivity in patients with non-Hodgkin lymphoma, Hodgkin lymphoma, or stage IV breast cancer that has returned after a period of improvement or does not respond to treatment. Injecting tiny amounts of anti-cancer drugs directly into tumors on the skin or in lymph nodes and diagnostic procedures, such as FDG-PET, may help to show which drugs work better in treating patients with non-Hodgkin lymphoma, Hodgkin lymphoma, or breast cancer.

Detailed description

PRIMARY OBJECTIVE: I. To assess the safety of in vivo in host drug sensitivity testing in patients with breast cancer and patients with lymphoma (nodal, extranodal masses, or cutaneous lesions). SECONDARY OBJECTIVES: I. To assess the feasibility of in vivo in host drug sensitivity testing in this patient population. II. To identify targeted therapies with potential activity in relapsed lymphoma and metastatic breast cancer. III. To evaluate the adverse event profile within each patient population. CORRELATIVE OBJECTIVES: I. To assess for apoptosis in response to intratumoral injection using known biomarkers (e.g., by morphology, Ki-67, caspace-3 assay as a marker of early apoptosis). II. To evaluate intratumoral biomarkers, intratumoral cell populations, and distribution, identify potential biomarkers that correlate with response to therapy based on individual therapies. OUTLINE: Patients undergo FDG-PET and receive saline intralesionally on day 1. Patients also receive up to five additional injections of gemcitabine hydrochloride, romidepsin, belinostat, carfilzomib, copanlisib hydrochloride, nivolumab, trastuzumab, daratumumab, obinutuzumab, pembrolizumab, or rituximab intralesionally per investigator on day 1. Beginning 5 days later, patients with nodal/extranodal mass undergo restaging FDG-PET and biopsy (if clinically feasible). Within 3-7 days, patients with cutaneous disease undergo restaging photography and biopsy. After completion of study treatment, patients are followed up at 3 months.

Conditions

Interventions

TypeNameDescription
DRUGBelinostatGiven intralesionally
DRUGCarfilzomibGiven intralesionally
DRUGCopanlisib HydrochlorideGiven intralesionally
BIOLOGICALDaratumumabGiven intralesionally
DRUGFludeoxyglucose F-18Undergo FDG-PET
DRUGGemcitabine HydrochlorideGiven intralesionally
OTHERLaboratory Biomarker AnalysisCorrelative studies
BIOLOGICALNivolumabGiven intralesionally
BIOLOGICALObinutuzumabGiven intralesionally
BIOLOGICALPembrolizumabGiven intralesionally
PROCEDUREPositron Emission TomographyUndergo FDG-PET
BIOLOGICALRituximabGiven intralesionally
DRUGRomidepsinGiven intralesionally
OTHERSalineGiven intralesionally
BIOLOGICALTrastuzumabGiven intralesionally

Timeline

Start date
2018-03-27
Primary completion
2022-08-26
Completion
2022-10-03
First posted
2018-02-14
Last updated
2025-05-26

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03432741. Inclusion in this directory is not an endorsement.