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Breast AdenocarcinomaPhase 1NCT03432741

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

A Phase 1 study testing Belinostat, Carfilzomib and Copanlisib Hydrochloride in people with Breast Adenocarcinoma and Metastatic Breast Carcinoma, run by Mayo Clinic at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Belinostat, Carfilzomib and Copanlisib Hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteUnited States
Study dates
27 Mar 2018to 3 Oct 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Pilot Safety and Feasibility Study of an In Vivo Sensitivity Screen Using a Direct Tumor Microinjection Technique and FDG-PET

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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:

  1. 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.

Being tested
Belinostat, Carfilzomib, Copanlisib Hydrochloride, Daratumumab, Fludeoxyglucose F-18
Medical subject headings
Breast Neoplasms, Hodgkin Disease, Mycosis Fungoides, Lymphoma, Non-Hodgkin, Lymphoma, T-Cell, Cutaneous, Lymphoma, B-Cell, Marginal Zone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BelinostatDrug

    Also called Beleodaq, PXD 101, PXD101

    Given intralesionally

  • CarfilzomibDrug

    Also called Kyprolis, PR-171

    Given intralesionally

  • Copanlisib HydrochlorideDrug

    Also called 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

    Given intralesionally

  • DaratumumabBiological

    Also called Anti-CD38 Monoclonal Antibody, Darzalex, HuMax-CD38, JNJ-54767414

    Given intralesionally

  • Fludeoxyglucose F-18Drug

    Also called 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18

    Undergo FDG-PET

  • Gemcitabine HydrochlorideDrug

    Also called dFdCyd, Difluorodeoxycytidine Hydrochloride, FF 10832, FF-10832

    Given intralesionally

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • NivolumabBiological

    Also called BMS-936558, CMAB819, MDX-1106, NIVO

    Given intralesionally

  • ObinutuzumabBiological

    Also called Anti-CD20 Monoclonal Antibody R7159, GA-101, GA101, Gazyva

    Given intralesionally

  • PembrolizumabBiological

    Also called Keytruda, Lambrolizumab, MK-3475, SCH 900475

    Given intralesionally

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan

    Undergo FDG-PET

  • RituximabBiological

    Also called ABP 798, BI 695500, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 Antibody

    Given intralesionally

  • RomidepsinDrug

    Also called Antibiotic FR 901228, Depsipeptide, FK228, FR901228

    Given intralesionally

  • SalineOther

    Also called ISOTONIC SODIUM CHLORIDE SOLUTION, Sodium Chloride 0.9%

    Given intralesionally

  • TrastuzumabBiological

    Also called ABP 980, ALT02, Anti-c-ERB-2, Anti-c-erbB2 Monoclonal Antibody

    Given intralesionally

Study groups in NCT03432741
Study groupRoleWhat they receive
Treatment (FDG-PET, direct tumor microinjection)ExperimentalPatients 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.
Receives: Drug: Belinostat; Drug: Carfilzomib; Drug: Copanlisib Hydrochloride; Biological: Daratumumab; Drug: Fludeoxyglucose F-18; Drug: Gemcitabine Hydrochloride; Other: Laboratory Biomarker Analysis; Biological: Nivolumab; Biological: Obinutuzumab; Biological: Pembrolizumab; Procedure: Positron Emission Tomography; Biological: Rituximab; Drug: Romidepsin; Other: Saline; Biological: Trastuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of drug sensitivity as measured by injection site skin reaction

    Skin reactions will be assessed using the Cancer Therapy Evaluation Program (CTEP) active version of the Common Terminology Criteria for Adverse Events (CTCAE) and will consist of any grade 3 or higher treatment-related pain, skin or subcutaneous tissue disorders. Incidence rates of skin reactions will be estimated by the number of patients with reactions divided by the total number of evaluable patients per disease type. Exact binomial 95% confidence intervals for the true incidence rate will be calculated.

    Measured: Up to 3 months

Secondary outcomes (4)

  1. Feasibility

    For Cohort I (Arms A \& B) and Cohort II (Arm D): The study will be determined to be feasible if at least 70% of the enrolled patients complete the injection and response evaluation. The feasibility rate will be estimated by the number of patients completed divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true feasibility rate will be calculated. For Cohort II (Arm C): The feasibility rate will be evaluated for the device regarding whether the device will be able to target the affected lymph nodes in at least 50% of the time. The feasibility rate will be estimated by the number of patients completed divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true feasibility rate will be calculated.

    Measured: Up to 3 months

  2. Nodal disease response rate

    Defined as a decrease in standardized uptake value (SUV) uptake by 25% at site of injection. Will be estimated by the number of injection sites with responses divided by the total number of injected sites. Exact binomial 95% confidence intervals for the true overall response rate will be calculated.

    Measured: Up to 5 days post injection

  3. Cutaneous response rate based upon the modified Severity Weighted Assessment Tool score

    Will be estimated by the number of injection sites with responses divided by the total number of injected sites. Exact binomial 95% confidence intervals for the true overall response rate will be calculated.

    Measured: Up to 7 days post injection

  4. Incidence of adverse events

    Will be evaluated using the CTEP active version of the CTCAE. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns.

    Measured: Up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2018
  2. Study start27 Mar 2018
  3. Primary completion26 Aug 2022
  4. Study completion3 Oct 2022

Why it stopped: funding - sponsor filing Chapter 11 bankruptcy

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03432741
Sponsor's protocol ID
MC1689
Other IDs
NCI-2018-00149, MC1689, 16-009337
Status last verified
May 2025
First submitted
8 Feb 2018
Last updated
26 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Belinostat, Carfilzomib and Copanlisib Hydrochloride in people with Breast Adenocarcinoma and Metastatic Breast Carcinoma, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: funding - sponsor filing Chapter 11 bankruptcy). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of drug sensitivity as measured by injection site skin reaction (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03432741.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2025.

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