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
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- STATUS
- Recruiting
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- End date
- May 1, 2023
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- participants needed
- 39
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- sponsor
- Mayo Clinic
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.
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.
Details
| Condition | 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 |
|---|---|
| Treatment | Rituximab, laboratory biomarker analysis, gemcitabine hydrochloride, positron emission tomography, Trastuzumab, Pembrolizumab, Obinutuzumab, Nivolumab, romidepsin, Fludeoxyglucose F-18, Saline, Daratumumab, Carfilzomib, Belinostat, Copanlisib Hydrochloride |
| Clinical Study Identifier | NCT03432741 |
| Sponsor | Mayo Clinic |
| Last Modified on | 22 March 2022 |
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