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About
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.
Full 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.
Enrollment
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Volunteers
Inclusion criteria
Age >= 18 years
Histologically proven of relapsed or refractory
Non-Hodgkin lymphoma (NHL) or Hodgkin lymphoma (HL) nodal or extranodal mass OR
Cutaneous T-cell lymphoma (CTCL) including mycosis fungoides (MF), as well as transformed MF OR
Breast adenocarcinoma with nodal or cutaneous metastases (stage 4)
Cohort I: For nodal/extranodal mass, presence of lesions that are amenable for injections as determined by interventional radiology
Measurable disease:
Candidate for further therapy and able to wait 7 days prior to start of next systemic therapy
Absolute neutrophil count (ANC) >= 1000/mm^3 (obtained =< 14 days prior to registration)
Platelet count >= 50,000/mm^3 (obtained =< 14 days prior to registration)
International normalized ratio (INR)/prothrombin time (PT) =< 1.5 (obtained =< 14 days prior to registration)
Negative serum or urine pregnancy test done =< 7 days prior to registration, for persons of childbearing potential only
Provide written informed consent
Willing to return to enrolling institution for follow-up
Willing to provide tissue samples for correlative research purposes
Exclusion criteria
Any of the following:
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Systemic corticosteroids between pre-PET and post-PET evaluation and biopsy
Prohibited treatments and or therapies
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Requires anticoagulation that cannot be discontinued prior to biopsy
Primary purpose
Allocation
Interventional model
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39 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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