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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-27

Study Completion Date

2022-10-03

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Intervention Type OTHER

Given intralesionally

Trastuzumab

Intervention Type BIOLOGICAL

Given intralesionally

Given intralesionally

Intervention Type BIOLOGICAL

Other Intervention Names

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Beleodaq PXD 101 PXD101 Kyprolis PR-171 5-Pyrimidinecarboxamide, 2-Amino-N-(2,3-dihydro-7-methoxy-8-(3-(4-morpholinyl)propoxy)imidazo(1,2-C)quinazolin-5-yl)-, Hydrochloride (1:2) Aliqopa BAY 80-6946 Dihydrochloride BAY-80-6946 Dihydrochloride Copanlisib Dihydrochloride Anti-CD38 Monoclonal Antibody Darzalex HuMax-CD38 JNJ-54767414 18FDG FDG Fludeoxyglucose (18F) fludeoxyglucose F 18 Fludeoxyglucose F18 Fluorine-18 2-Fluoro-2-deoxy-D-Glucose Fluorodeoxyglucose F18 dFdCyd Difluorodeoxycytidine Hydrochloride FF 10832 FF-10832 FF10832 Gemcitabine HCI Gemzar LY-188011 LY188011 BMS-936558 CMAB819 MDX-1106 NIVO Nivolumab Biosimilar CMAB819 ONO-4538 Opdivo Anti-CD20 Monoclonal Antibody R7159 GA-101 GA101 Gazyva huMAB(CD20) R7159 RO 5072759 RO-5072759 RO5072759 Keytruda Lambrolizumab MK-3475 SCH 900475 Medical Imaging, Positron Emission Tomography PET PET Scan Positron Emission Tomography Scan Positron-Emission Tomography proton magnetic resonance spectroscopic imaging ABP 798 BI 695500 C2B8 Monoclonal Antibody Chimeric Anti-CD20 Antibody CT-P10 IDEC-102 IDEC-C2B8 IDEC-C2B8 Monoclonal Antibody MabThera Monoclonal Antibody IDEC-C2B8 PF-05280586 Rituxan Rituximab ABBS Rituximab Biosimilar ABP 798 Rituximab Biosimilar BI 695500 Rituximab Biosimilar CT-P10 Rituximab Biosimilar GB241 Rituximab Biosimilar IBI301 Rituximab Biosimilar JHL1101 Rituximab Biosimilar PF-05280586 Rituximab Biosimilar RTXM83 Rituximab Biosimilar SAIT101 Rituximab Biosimilar SIBP-02 rituximab biosimilar TQB2303 rituximab-abbs RTXM83 Truxima Antibiotic FR 901228 Depsipeptide FK228 FR901228 Istodax N-[(3S,4E)-3-Hydroxy-7-mercapto-1-oxo-4-heptenyl]-D-valyl-D-cysteinyl-(2Z)-2-amino-2-butenoyl-L-valine, (4->1) Lactone, Cyclic ISOTONIC SODIUM CHLORIDE SOLUTION Sodium Chloride 0.9% ABP 980 ALT02 Anti-c-ERB-2 Anti-c-erbB2 Monoclonal Antibody Anti-ERB-2 Anti-erbB-2 Anti-erbB2 Monoclonal Antibody Anti-HER2/c-erbB2 Monoclonal Antibody Anti-p185-HER2 c-erb-2 Monoclonal Antibody HER2 Monoclonal Antibody Herceptin Herceptin Biosimilar PF-05280014 Herceptin Trastuzumab Biosimilar PF-05280014 Herzuma Kanjinti MoAb HER2 Monoclonal Antibody c-erb-2 Monoclonal Antibody HER2 Ogivri Ontruzant PF-05280014 rhuMAb HER2 RO0452317 SB3 Trastuzumab Biosimilar ABP 980 Trastuzumab Biosimilar ALT02 trastuzumab biosimilar EG12014 Trastuzumab Biosimilar HLX02 Trastuzumab Biosimilar PF-05280014 Trastuzumab Biosimilar SB3 Trastuzumab Biosimilar SIBP-01 Trastuzumab-anns Trastuzumab-dkst Trastuzumab-dttb Trastuzumab-pkrb Trastuzumab-qyyp Trazimera

Eligibility Criteria

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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)

* NOTE: Patients must be refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for their condition
* NOTE: The patient must not be a candidate for any curative therapy or any known life-prolonging therapy
* Cohort I: For nodal/extranodal mass, presence of lesions that are amenable for injections as determined by interventional radiology

* NOTE: Nodal or extranodal mass must be palpable and easily accessible; masses such as mediastinum, retroperitoneum, within solid organs, spinal sites, central nervous system (CNS) sites, etc., are NOT allowed
* Measurable disease:

* For nodal or extranodal disease (lymphoma or breast): must have at least 2 lesions that are \>= 20 mm (2.0 cm) in the longest diameter by physical exam and/or on cross-sectional imaging and measurable in two perpendicular dimensions per computed tomography PET-computed tomography (CT); For Cohort I, the lesions must be amenable to intralesional injections as determined by interventional radiology (including tumors that can be safely accessed using imaging guidance and treated with minimal risk to adjacent structures)
* For cutaneous lesions (lymphoma or breast): at least two visible, non-infected skin lesions that are greater than 1 cm and are amenable to intralesional injection as determined by investigator
* 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:

* Pregnant persons
* Nursing persons
* Persons of childbearing potential who are unwilling to employ adequate contraception
* 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

* Autologous stem cell transplant (ASCT) =\< 12 weeks prior to registration
* Prior chemotherapy =\< 2 weeks prior to registration
* Prior treatment with nitrosureas =\< 4 weeks prior to registration
* Therapeutic anticancer antibodies =\< 2 weeks prior to registration
* Radio- or toxin immunoconjugates =\< 4 weeks prior to registration
* Radiation therapy to the injected area =\< 2 weeks prior to registration
* Major surgery =\< 2 weeks prior to registration
* 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

* Note: Exception if able to hold antiplatelet agents 7 days prior to the injections and biopsy
* NOTE: Low molecular weight heparin (LMWH) will be allowed for bridging if on warfarin
* NOTE: Heparin for line patency without detectable lab abnormalities for coagulation will be allowed

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No