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
NCT03432741 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17
Last updated 2025-05-26
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.
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
Interventions
- DRUG
-
Belinostat
Given intralesionally
- DRUG
-
Given intralesionally
- DRUG
-
Copanlisib Hydrochloride
Given intralesionally
- BIOLOGICAL
-
Given intralesionally
- DRUG
-
Fludeoxyglucose F-18
Undergo FDG-PET
- DRUG
-
Gemcitabine Hydrochloride
Given intralesionally
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
- BIOLOGICAL
-
Given intralesionally
- BIOLOGICAL
-
Given intralesionally
- BIOLOGICAL
-
Given intralesionally
- PROCEDURE
-
Positron Emission Tomography
Undergo FDG-PET
- BIOLOGICAL
-
Given intralesionally
- DRUG
-
Romidepsin
Given intralesionally
- OTHER
-
Saline
Given intralesionally
- BIOLOGICAL
-
Given intralesionally
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Grzegorz S. Nowakowski, M.D. · Mayo Clinic
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-03-27
- Primary Completion
- 2022-08-26
- Completion
- 2022-10-03
- FDA Drug
- Yes
Countries
- United States
Study Locations
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