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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT03432741
Phase
PHASE1
Status
Terminated

Conditions

  • Breast Adenocarcinoma
  • Metastatic Breast Carcinoma
  • Recurrent Breast Carcinoma
  • Recurrent Hodgkin Lymphoma
  • Recurrent Mycosis Fungoides
  • Recurrent Non-Hodgkin Lymphoma
  • Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
  • Refractory Breast Carcinoma
  • Refractory Hodgkin Lymphoma
  • Refractory Mycosis Fungoides
  • Refractory Nodal Marginal Zone Lymphoma
  • Refractory Non-Hodgkin Lymphoma
  • Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
  • Stage IV Breast Cancer AJCC v6 and v7

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Belinostat — DRUG
    Given intralesionally
  • Carfilzomib — DRUG
    Given intralesionally
  • Copanlisib Hydrochloride — DRUG
    Given intralesionally
  • Daratumumab — BIOLOGICAL
    Given intralesionally
  • Fludeoxyglucose F-18 — DRUG
    Undergo FDG-PET
  • Gemcitabine Hydrochloride — DRUG
    Given intralesionally
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Nivolumab — BIOLOGICAL
    Given intralesionally
  • Obinutuzumab — BIOLOGICAL
    Given intralesionally
  • Pembrolizumab — BIOLOGICAL
    Given intralesionally
  • Positron Emission Tomography — PROCEDURE
    Undergo FDG-PET
  • Rituximab — BIOLOGICAL
    Given intralesionally
  • Romidepsin — DRUG
    Given intralesionally
  • Saline — OTHER
    Given intralesionally
  • Trastuzumab — BIOLOGICAL
    Given intralesionally

Study Details

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.

Key Dates

Start date
Mar 27, 2018
Status verified
May 2025
Primary completion
Aug 26, 2022
Completion
Oct 3, 2022

Study Design

Enrollment
17 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (FDG-PET, direct tumor microinjection)
    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.

Primary Outcome Measure

Incidence of drug sensitivity as measured by injection site skin reaction [ Time Frame: Up to 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905-

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By research site
Mayo Clinic in Rochester· Rochester, MN

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