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
Last updated on July 2021Recruitment
- Recruitment Status
- Suspended
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Breast Adenocarcinoma
- Recurrent Breast Carcinoma
- Recurrent Hodgkin Lymphoma
- Recurrent Mycosis Fungoides
- Recurrent Non-Hodgkin Lymphoma
- Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
- Refractory Hodgkin Lymphoma
- Stage IV Breast Cancer AJCC v6 and v7
- Refractory Mycosis Fungoides
- Refractory Nodal Marginal Zone Lymphoma
- Refractory Non Hodgkin Lymphoma
- Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To assess the safety of in vivo in host drug sensitivity testing in patients with breast cancer and patients with lymphoma (nodal, extranodal or cutaneous lesions). SECONDARY OBJECTIVES: I. To assess the feasibility of in vivo in host drug sensitivity testing in this patient p...
PRIMARY OBJECTIVES: I. To assess the safety of in vivo in host drug sensitivity testing in patients with breast cancer and patients with lymphoma (nodal, extranodal 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. TERTIARY 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, nivolumab, trastuzumab, daratumumab, obinutuzumab, pembrolizumab, or rituximab intralesionally per investigator on day 1. Beginning 5 days later, patients with nodal disease undergo restaging FDG-PET and biopsy (if clinically feasible). Within 3-7 days, patients with cutaneous disease undergo restaging FDG-PET, photography, and biopsy. After completion of study treatment, patients are followed up at 3 months.
Tracking Information
- NCT #
- NCT03432741
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Grzegorz Nowakowski Mayo Clinic