Neoplasms

All Conditions

Rare Diseases

Cholangiocarcinoma

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Bile Duct Cancer

Intrahepatic Cholangiocarcinoma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Gemcitabine

Dexamethasone

Oxaliplatin

Dexamethasone acetate

Floxuridine

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Antimetabolites

Surgical HAI pump placement. 2. HAI FUDR \[(0.12 mg/kg/day) x wt (kg) x (30ml) / pump flow rate \] and dexamethasone \[1 mg/day \* 30\] / pump flow rate \] on Day 1 of each cycle. Chemotherapy with HAI FUDR/Dex will commence no sooner than 14 days postsurgical placement of HAI pump. 3. Gemcitabine (800 mg/m2 IV over 30 minutes) and oxaliplatin (85 mg/ m2 IV over 120 minutes on Days 1 and 15 of each cycle; however, for patients in Arm 1, initiation of systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first dose of systemic chemotherapy will be given on Cycle 1, Day 15, and then every 2 weeks thereafter.

Gemcitabine (800 mg/m2 IV over 30 minutes) and oxaliplatin (85 mg/m2 IV over approximately 120 minutes) on Days 1 and 15 of each 28-day cycle.For patients in Arm 2, systemic therapy will be administered on Days 1 and Day 15 of each Cycle on a 28-day cycle basis, compromised of Gemcitabine and Oxaliplatin. If a patient randomized to Arm 2 has intrahepatic progression on any follow-up scan during study treatment, that patient will be eligible to crossover to Arm 1 and commence to pump placement surgery and HAI FUDR treatment. Patients with any extrahepatic progression will not be eligible to utilize the crossover arm. Arm 2 patients will have 28 days from date of the scan showing intrahepatic progression to proceed to the crossover arm.

Floxuridine (FUDR)

Implanted hepatic arterial infusion pump by surgical oncology, to deliver HAI therapy

Implanted Medical Device

Andrea Cercek, MD

William Jarnagin, MD

Jonathan Hernandez, MD

William Chapman, MD

Andera Cercek, MD

Andrew Cercek, MD

Michael Lidsky, MD

This study will compare the safety and effects of HAI floxuridine and dexamethasone combined with the standard chemotherapy drugs gemcitabine and oxaliplatin (GemOx) with those of GemOx alone in people with untreated cholangiocarcinoma that cannot be removed with surgery. The researchers want to find out whether the study treatment works better than the standard chemotherapy to delay progression of disease. For the study treatment to be considered better than the standard treatment, the study treatment should increase the time until progression of disease by an average of 3 months, compared with the usual approach.

This is a multi-center, prospective randomized controlled phase II study.

Gemcitabine and Oxaliplatin Chemotherapy With or Without a Floxuridine and Dexamethasone Pump in People With Cholangiocarcinoma That Cannot Be Removed With Surgery

A Randomized Phase II Study of Systemic Chemotherapy With or Without HAI FUDR/Dexamethasone in Patients With Unresectable Intrahepatic Cholangiocarcinoma

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Memorial Sloan Kettering Cancer Center

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Carcinoma In Situ

Carcinoma in Situ

Breast Diseases

Skin Diseases

Patients undergo image-guided placement of the SCOUT reflector prior to course 2 of standard of care neoadjuvant chemotherapy. Patients undergo standard of care surgery approximately 4-8 weeks after chemotherapy completion.

Therapeutic Conventional Surgery

Jennifer Baker, MD

This pilot clinical trial will evaluate whether the SCOUT reflector can be used to tag abnormal lymph nodes in patients with breast cancer prior to chemotherapy for targeted removal at the time of surgery. The SCOUT localization system with the SAVI reflector is non-radioactive and completely internal so can be placed into an abnormal lymph node prior to chemotherapy treatment, which theoretically will allow easier identification and therefore more reliable targeting of the abnormal lymph node for surgical removal.

PRIMARY OBJECTIVES:

I. Percentage of patients with successful retrieval of the reflector confirmed by specimen radiography.

II. Percentage of patients with successful retrieval of the biopsied node, confirmed by presence of clip, biopsy changes or treatment-related changes on pathology.

SECONDARY OBJECTIVES:

I. Total number of lymph nodes removed. II. Percentage of patients in which clipped node was a sentinel node. III. Percentage of patients with nodal pathologic complete response (PCR). IV. Residual cancer burden (RCB) score for patients with residual nodal disease.

V. Percentage of patients requiring axillary dissection. VI. Days prior to surgery of reflector insertion.

OUTLINE:

Patients undergo image-guided placement of the SCOUT reflector prior to course 2 of standard of care neoadjuvant chemotherapy. Patients undergo standard of care surgery approximately 4-8 weeks after chemotherapy completion.

SCOUT Reflector for Tagging Lymph Nodes for Targeted Removal in Patients With Breast Cancer

Using Radar Technology to Tag Abnormal Lymph Nodes for Removal During Surgery Following Neoadjuvant Chemotherapy

All adverse events due to these procedures will be recorded and reported to the institutional review board (IRB).

Faxitron bioptics, LLC

Jonsson Comprehensive Cancer Center

Patients undergo mammogram or ultrasound for image-guided placement of the radiofrequency tag within 30 days of surgery and then undergo radiofrequency-guided localization during surgery.

Undergo mammogram for image-guided placement of radiofrequency tag

Mammography

Questionnaire Administration

Undergo radiofrequency-guided localization

Radiofrequency (RFID) -Guided Localization

Undergo ultrasound for image-guided placement of radiofrequency tag

Ultrasonography

Maggie DiNome, MD

This pilot clinical trial studies radiofrequency technology in locating non-palpable breast lesions in patients undergoing surgery. Placing a miniature radiofrequency tag or microchip in the breast lesion before surgery and using a handheld device to guide doctors during surgery may improve surgical outcomes in patients with non-palpable breast lesions.

PRIMARY OBJECTIVES:

I. Evaluate the feasibility of utilizing a new Federal Drug Administration (FDA)-cleared radiofrequency tag for localization of non-palpable breast lesions and provide preliminary data for a larger study.

OUTLINE:

Patients undergo mammogram or ultrasound for image-guided placement of the radiofrequency tag within 30 days of surgery and then undergo radiofrequency-guided localization during surgery.

After completion of study, patients are followed up within 2 weeks.

Radiofrequency Identification Technology in Locating Non-palpable Breast Lesions in Patients Undergoing Surgery

Pilot Trial Evaluating a Miniature Radiofrequency Tag for Localization of Non-palpable Breast Lesions for Surgery

Patients with successful radiofrequency tag placement

Patients with successful radiofrequency tag retrieval.

Mean number of days before surgery that radiofrequency tag was placed.

The patient experience with image-guided placement of the radio frequency Identification (RFID) tag.This assessments was captured using Likert-type questionnaires. Individual question responses for the patient and physician questionnaires ranged from 1 to 5 with the score of 5 representing the maximum positive or favorable response to each question. The following choices were included in each questionnaire:

1. Strongly disagree
2. Disagree
3. Neutral
4. Agree
5. Strongly Agree

Responses of the individual scales were added to create a total score, which would include a possible total range of 5 to a maximum of 25 points. 25 is the maximum positive or favorable response.

Movement of radiofrequency tag from point of placement

Patients with margins of excisable tissue remaining.

The radiologist's experience with image-guided placement of the RFID tag.This assessments was captured using Likert-type questionnaires. Individual question responses for the patient and physician questionnaires ranged from 1 to 5 with the score of 5 representing the maximum positive or favorable response to each question. The following choices were included in each questionnaire:

1. Strongly disagree
2. Disagree
3. Neutral
4. Agree
5. Strongly Agree

Responses of the individual scales were added to create a total score, which would include a possible total range of 5 to a maximum of 25 points. 25 is the maximum positive or favorable response.

The surgeon's experience with image-guided placement of the RFID tag.This assessments was captured using Likert-type questionnaires. Individual question responses for the patient and physician questionnaires ranged from 1 to 5 with the score of 5 representing the maximum positive or favorable response to each question. The following choices were included in each questionnaire:

1. Strongly disagree
2. Disagree
3. Neutral
4. Agree
5. Strongly Agree

Responses of the individual scales were added to create a total score, which would include a possible total range of 5 to a maximum of 25 points. 25 is the maximum positive or favorable response.

Amount of tissue removed with radiofrequency tag.

AstraZeneca

Patients undergo mammogram or ultrasound for image-guided placement of the radiofrequency tag within 30 days of surgery and then undergo radiofrequency-guided localization during surgery.

Implanted Medical Device: Radiofrequency tag

Mammography: Undergo mammogram for image-guided placement of radiofrequency tag

Questionnaire Administration: Ancillary studies

Radiofrequency-Guided Localization: Undergo radiofrequency-guided localization

Ultrasonography: Undergo ultrasound for image-guided placement of radiofrequency tag

Diagnostic (Radiofrequency-guided Localization)

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

Mammogram

Ultrasound

Imaging Diagnosis

Benign

Cancerous

Lesion Diagnosis

Atypical ductal hyperplasia (ADH)

Ductal carcinoma in situ (DCIS)

DCIS with microinvasion

Encapsulated papillary carcinoma

Fibroadenoma with atypia

Glomus tumor

Invasive ductal carcinoma (IDC)

Invasive lobular carcinoma (ILC)

Lobular neoplasia

Papilloma

Phyllodes, benign

Radial Scar

Stromal Fibrosis

Lesion Category

Mark Glover

Patients With Successful Placement of the Radiofrequency Tag Under Radiographic Guidance Confirmed by Mammography

Patients With Successful Retrieval of the Radiofrequency Tag Confirmed by Specimen Radiography

Days Prior to Surgery of Insertion of Marker

Patient Experience With Image-guided Placement of Tag as Rated by a Patient Questionnaire

Patients With Cancer Requiring Re-excision

Patients With Documented Migration of Marker

Patients With Positive Margins on Initial Lumpectomy Using Radiofrequency Identification Technology

Radiologist's Experience Placing Radiofrequency Tag Compared to Wire Localization as Measured by a Radiologist's Questionnaire

Surgeon's Experience Using Radiofrequency Tag to Guide Resection Compared to Wire Localization as Measured by a Surgeon's Questionnaire

Volume (cm3), of Tissue Removed With Specimen With Tag (Not Including Shave Margins, if Taken)

Overall Study

Carcinoma, Ductal

Micronutrients

Fibrinolytic Agents

Anticoagulants

Hematinics

Dermatologic Agents

Anti-Infective Agents

Vitamins

Leucovorin

Fluorouracil

Irinotecan

Levoleucovorin

Heparin

BB 1101

Folic Acid

Liver Extracts

Calcium heparin

Ichthammol

Deoxyuridine

HIV Protease Inhibitors

Protease Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

Topoisomerase I Inhibitors

Antidotes

Protective Agents

Vitamin B Complex

Trace Elements

Folinic Acid

Folate

Vitamin B9

Treatment Period 1 - mFOLFIRINOX for 4 cycles (cycle = 14 days) Cycle 1

* Oxaliplatin 85 mg/m2 intravenously (iv) over 2 hours
* Folinic acid 400 mg/m2 iv over 2 hours
* Irinotecan 165 mg/m2 iv over 90 minutes
* Fluorouracil 400 mg/m2 iv bolus after folinic acid
* Fluorouracil 2,400 mg/m2 continuous infusion over 46 hours

Dosages on Cycle 2, 3, and 4 will be reduced by 25% Treatment Period 2 - HAI delivery of floxuridine + mFOLFIRI for 2 cycles (cycle = 28 days)

* Floxuridine-DEX (with heparin and saline) - 0.12 mg/kg/day; via HAI pump, adjusted for weight and flow rate

mFOLFIRI on Day 15

* Irinotecan 180 mg/m2 iv over 30 minutes to 1 hour
* Folinic acid 400mg/m2 iv over 30 minutes to 1 hour
* 5-FU 1000 mg/m2 continuous infusion over 46 hours

Quality-of-Life Assessment

Skye C Mayo, MD, MPH

This phase II trial studies the efficacy and safety of systemic induction of mFOLFIRINOX, followed by hepatic arterial infusion (HAI) floxuridine-dexamethasone administered concurrently with systemic mFOLFIRI in treating patients with liver-dominant intrahepatic cholangiocarcinoma (ICC) that cannot be removed by surgery (unresectable). Drugs used in chemotherapy regimens, such as mFOLFIRINOX and mFOLFIRI (Oxaliplatin, Irinotecan, Fluorouracil, Folinic acid, Floxuridine) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Delivering chemotherapy via HAI (hepatic arterial infusion) can allow for liver-directed treatment while limiting toxic side effects typically seen with traditional chemotherapy.

PRIMARY OBJECTIVES:

I. Assess the toxicity, safety and tolerability of hepatic arterial infusion (HAI) floxuridine therapy.

II. Evaluate the efficacy of systemic induction of oxaliplatin, leucovorin calcium (folinic acid), irinotecan hydrochloride, and fluorouracil (modified \[m\] FOLFIRINOX), followed by HAI of floxuridine-dexamethasone (DEX) administered concurrently with systemic irinotecan hydrochloride, leucovorin calcium (folinic acid), and fluorouracil (mFOLFIRI).

SECONDARY OBJECTIVES:

I. To evaluate tumor response to treatment and participant survival. II. Assess rate of post-operative complications. III. Evaluate serious post-operative complications following surgical placement of the HAI pump.

EXPLORATORY OBJECTIVES:

I. To assess the radiographic response using diffusion weighted imaging (DWI) as part of an magnetic resonance imaging (MRI) examination.

II. Determine whether, compared to historical controls, induction mFOLFIRINOX combined with integrated HAI of floxuridine-DEX and systemic mFOLFIRI treatment will improve patient quality of life (QoL) including fatigue and depression.

III. Investigate molecular signature associated with intrahepatic cholangiocarcinoma (ICC).

IV. Generate a differential expression pattern of ribonucleic acid (RNA)s (microRNA \[miR\] and messenger RNA \[mRNA\]) in patients with ICC derived from tumor samples compared to adjacent normal liver samples as well as lymphatic tissue, blood and bile).

V. Characterize the changes in the population of circulating hybrid cells (CHCs) pre-, during, and post-treatment.

OUTLINE: This is a phase II, single arm, study that consists of a two-part treatment plan (Treatment Periods 1 and 2) of systemic induction of mFOLFIRINOX, followed by HAI floxuridine-DEX administered concurrently with systemic mFOLFIRI. The first 6 patients enrolled will be part of a safety run-in, after which enrollment could be expanded to additional 24.

After laparoscopic staging, eligible patients will receive a systemic regimen of mFOLFIRINOX with 25% dose reduction of oxaliplatin, irinotecan, and fluorouracil administered every 2-weeks for 4 cycles (8 weeks) (Treatment Period 1). After completing mFOLFIRINOX induction, participants' disease will be re-evaluated by MRI/CT imaging. Only those that achieve disease control based on RECIST criteria (v1.1) will be eligible for HAI therapy via a laparotomy and placement of a HAI pump. (Treatment Period 2).

After completing 2 cycles of HAI treatment with concurrent FOLFIRI, participants will undergo repeat MRI/CT imaging to assess disease response. An image-guided liver biopsy will be performed after completion of the 8 weeks of treatment of HAI floxuridine/dexamethasone combined with systemic mFOLFIRI of Treatment Period 2. Optional extrahepatic biopsies may be collected from participants demonstrating disease progression. Participants with controlled disease (as defined by RECIST criteria) may receive additional cycles of HAI-delivered floxuridine and dexamethasone, along with systemic administration of mFOLFIRI. Completion of QoL questionnaires and interviews will take place at baseline, at the end of treatment period 1 and prior to each HAI treatment cycle, and again at the end of study, and again from the End of Study up to 24 months post study.

mFOLFIRINOX Followed by Hepatic Arterial Infusion of Floxuridine and Dexamethasone With Systemic mFOLFIRI for Unresectable Liver-dominant Intrahepatic Cholangiocarcinoma

A Phase II Study of Induction Systemic mFOLFIRINOX Followed by Hepatic Arterial Infusion of Floxuridine and Dexamethasone Given Concurrently With Systemic mFOLFIRI as a First-Line Therapy in Patients With Unresectable Liver-Dominant Intrahepatic Cholangiocarcinoma

Defined by unacceptable elevation in liver enzymes, or radiographic evidence of biliary sclerosis on computed tomography (CT)/magnetic resonance imaging (MRI) (as measured following the completion of 2 cycles of hepatic arterial infusion \[HAI\] in Treatment Period 2).

DCR is defined as the percentage of patients who have achieved complete response (CR), partial response (PR), or stable disease (SD). Measured from beginning of Treatment Period 2 to end of Treatment Period 2 during treatment with HAI + systemic chemotherapy (SYS).

Measured from beginning of Treatment Period 1 to end of Treatment Period 2 (i.e., from the beginning of the entire treatment protocol until the end).

Measured from beginning of Treatment Period 1 to end of Treatment Period 1 (i.e., during the treatment with oxaliplatin, irinotecan, and fluorouracil \[FOLFIRINOX\] alone).

Measured from beginning of Treatment Period 1 to end of Treatment Period 1 (i.e., during the treatment with FOLFIRINOX alone).

Measured from beginning of Treatment Period 2 to up to 1 year after the end of Treatment Period 2 (i.e., during the treatment with HAI floxuridine + irinotecan hydrochloride and leucovorin calcium \[folinic acid\] \[modified(m)FOLFIRI\].

Measured at the end of Treatment Period 1, at the end of Treatment Period 2, and at 1 year, and the whole study period.

Defined as complications occurring within 9 weeks following surgery and \>= grade III per the Clavien-Dindo classification system.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Gemcitabine and Oxaliplatin Chemotherapy With or Without a Floxuridine and Dexamethasone Pump in People With Cholangiocarcinoma That Cannot Be Removed With Surgery	NCT04891289	Intrahepatic Ch...	Gemcitabine Oxaliplatin Dexamethasone Floxuridine (FU... Implanted Medic...	18 Years -	Memorial Sloan Kettering Cancer Center
SCOUT Reflector for Tagging Lymph Nodes for Targeted Removal in Patients With Breast Cancer	NCT03411070	Positive Axilla... Stage 0 Breast ... Stage I Breast ... Stage IA Breast... Stage IB Breast... Stage II Breast... Stage IIA Breas... Stage IIB Breas... Stage III Breas... Stage IIIA Brea... Stage IIIB Brea... Stage IIIC Brea...	Implanted Medic... Therapeutic Con...	18 Years -	Jonsson Comprehensive Cancer Center
Radiofrequency Identification Technology in Locating Non-palpable Breast Lesions in Patients Undergoing Surgery	NCT03202472	Breast Neoplasm Lesion	Implanted Medic... Mammography Questionnaire A... Radiofrequency ... Ultrasonography	19 Years -	Jonsson Comprehensive Cancer Center
Gemcitabine and Oxaliplatin Chemotherapy With or Without a Floxuridine and Dexamethasone Pump in People With Cholangiocarcinoma That Cannot Be Removed With Surgery	NCT04891289	Intrahepatic Ch...	Gemcitabine Oxaliplatin Dexamethasone Floxuridine (FU... Implanted Medic...	18 Years -	Memorial Sloan Kettering Cancer Center
Radiofrequency Identification Technology in Locating Non-palpable Breast Lesions in Patients Undergoing Surgery	NCT03202472	Breast Neoplasm Lesion	Implanted Medic... Mammography Questionnaire A... Radiofrequency ... Ultrasonography	19 Years -	Jonsson Comprehensive Cancer Center
mFOLFIRINOX Followed by Hepatic Arterial Infusion of Floxuridine and Dexamethasone With Systemic mFOLFIRI for Unresectable Liver-dominant Intrahepatic Cholangiocarcinoma	NCT04251715	Liver and Intra... Stage III Intra... Stage IIIA Intr... Stage IIIB Intr... Stage IV Intrah... Unresectable In...	Dexamethasone Floxuridine Implanted Medic... Irinotecan Leucovorin Oxaliplatin Quality-of-Life...	18 Years -	OHSU Knight Cancer Institute

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