Neoplasms

All Conditions

Rare Diseases

Carcinoma

Cholangiocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Bile Duct Cancer

Intrahepatic Cholangiocarcinoma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Gemcitabine

Oxaliplatin

Dexamethasone

Dexamethasone acetate

Floxuridine

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Antimetabolites

All patients receive HAI FUDR (\[0.12 mg/kg/day kg 30\] / pump flow rate)\& dexamethasone ({1 mg/m2/day30} 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. All patients receive Gemcitabine (800 mg/m2 IV over 30 minutes) \& Oxaliplatin (85 mg/m2 IV over 120 minutes) on Days 1 \& 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, \& then every 2 weeks thereafter. Clinical MRI examinations of the abdomen \& pelvis are obtained at baseline following surgery, prior to treatment initiation \& 4 weeks after initiation of HAI FUDR. Subsequently, the patient will undergo MRI approximately at months 3, 6 \& 9 thereafter A non-contrast CT of chest, abdomen \& pelvis will also be obtained as part of routine clinical care.

All patients receive HAI FUDR (\[0.12 mg/kg/day kg 30\] / pump flow rate)\& dexamethasone ({1 mg/m2/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. All patients receive Gemcitabine (800 mg/m2 IV over 30 minutes) \& Oxaliplatin (85 mg/m2 IV over 120 minutes) on Days 1 \& 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, \& then every 2 weeks thereafter. Clinical MRI examinations of the abdomen \& pelvis are obtained at baseline following surgery, prior to treatment initiation \& 4 weeks after initiation of HAI FUDR. Subsequently, the patient will undergo MRI approximately at months 3, 6 \& 9 thereafter A non-contrast CT of chest, abdomen \& pelvis will also be obtained as part of routine clinical care.

All patients receive will receive gemcitabine alone with HAI FUDR/Dex Gemcitabine (800 mg/m2 IV over 30 minutes) alone on Days 1 and 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, and then every 2 weeks thereafter.

Floxuridine (FUDR)

dexamethasone

Research blood draws

William Jarnagin, MD

The purpose of this study is to use both, liver pump treatment and systemic chemotherapy, to assess the effects this type of treatment has on the patient and the tumor. Liver pump treatment uses a metal pump that is surgically placed in the abdomen and gives chemotherapy directly to the liver. Systemic chemotherapy gives chemotherapy through a vein \[intravenously (IV)\] and treats the whole body. This type of treatment has been done before and had shown that people with both pump and systemic chemotherapy had improved results. The investigators hope that this combination of treatments improves the response to chemotherapy and reduces the spread of the disease.

Another purpose of this study is to learn the clinical importance of a specific type of MRI scan. The investigators would like to see if this type of MRI will help predict the response to the treatment and see if they could help the physician with their treatment plan. These scans will be done at specific time points.

The last purpose of this study is to learn more about how the tumor interacts with the chemotherapy. This will be done through a biopsy taken during surgery and blood draws at specific time points.

Permission from patients entering the study will be obtained to take normal and tumor liver biopsies at the time of surgery. These samples are voluntary and optional.

Hepatic Arterial Infusion (HAI) With Floxuridine (FUDR) and Dexamethasone (Dex) Combined With Systemic Gemcitabine and Oxaliplatin in Patients With Unresectable Intrahepatic Cholangiocarcinoma (ICC)

A Phase II Study of Hepatic Arterial Infusion (HAI) With Floxuridine (FUDR) and Dexamethasone (Dex) Combined With Systemic Gemcitabine and Oxaliplatin in Patients With Unresectable Intrahepatic Cholangiocarcinoma (ICC)

Treatment evaluation will be done using RECIST (version 1.1)

This study will investigate DCE-MRI as potential imaging biomarkers and will measure tumor perfusion parameters and diffusion coefficients before initiating treatment and on follow-up MRI scans during treatment.

This study will investigate diffusion weighted imaging (DWI) as potential imaging biomarkers and will measure tumor perfusion parameters and diffusion coefficients before initiating treatment and on follow-up MRI scans during treatment.

Memorial Sloan Kettering Cancer Center

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Durvalumab

Pomalidomide

Antineoplastic Agents, Immunological

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Intravenous (IV) durvalumab at assigned dose level (750, 1500, 2250, or 3000 mg) over 1 hour on day 1 of a 28-day cycle

IV durvalumab at assigned dose level (750, 1500, 2250, or 3000 mg) over 1 hour on day 1 of a 28-day cycle and Oral POM 4 mg/day on Days 1 to 21 of each 28-day treatment cycle

IV durvalumab at assigned dose level (750, 1500, 2250, or 3000 mg) over 1 hour on day 1 of a 28-day cycle with Oral POM 4 mg/day on Days 1 to 21 of each 28-day treatment cycle and Oral dex 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15, and 22 of a 28-day cycle

Lars Sternas, MD, PhD

This is a multicenter, open-label, Phase 1b study to determine the recommended dose and regimen of durvalumab either as monotherapy or in combination with POM with or without low dose dex in subjects with RRMM. The study will consist of a dose-finding portion as well as a parallel dose-expansion portion to determine the optimal dose and regimen.

On 05 Sep 2017, a Partial Clinical Hold was placed on this study by the United States (US) Food and Drug Administration (FDA). The decision by the FDA was based on data related to risks of anti-programmed cell death-1 (PD-1) antibody, pembrolizumab, in combination with IMiDs® immunomodulatory drugs in patients with multiple myeloma. As a result, enrollment into this study has been discontinued. Subjects who are receiving clinical benefit, based on the discretion of the investigator, may remain on study treatment after being reconsented.

A Study to Determine Dose and Regimen of Durvalumab as Monotherapy or in Combination With Pomalidomide With or Without Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma

A Phase IB Multicenter, Open-label Study To Determine The Recommended Dose And Regimen Of Durvalumab (MEDI4736) Either As Monotherapy or In Combination With Pomalidomide (POM) With Or Without Low-Dose Dexamethasone (DEX) In Subjects With Relapsed And Refractory Multiple Myeloma (RRMM)

Number of participants with DLTs in the first cycle of treatment

Number of participants with adverse events

Tumor response, including progressive disease (PD) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria

Time from first dose to the first documentation of response (Partial Response \[PR\] or greater)

Is defined as time from the earliest date of documented response (partial response (PR) or better) to the earliest date when disease progression was confirmed

Celgene

Lymphoma

Lymphoma, Mantle-Cell

Lymphatic Diseases

Lymphoma, Non-Hodgkin

Lymphosarcoma

Mantle Cell Lymphoma

Lenalidomide

Lenalidomide will be supplied as 5 mg and 25 mg capsules for oral administration.Dexamethasone (Soldesam 0.2%) will be supplied as 20 mg liquid for oral administration (1 bottle = 20 mg; daily dose = 2 bottles = 40 mg).

Lenalidomide and Dexametasone

Francesco Zaja, MD

This is a prospective, multicenter phase II trial designed to evaluate the safety and activity of the combination of Lenalidomide (Len) and Dexamethasone (Dex) in patients with relapsed/refractory mantle cell lymphoma (MCL).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Hepatic Arterial Infusion (HAI) With Floxuridine (FUDR) and Dexamethasone (Dex) Combined With Systemic Gemcitabine and Oxaliplatin in Patients With Unresectable Intrahepatic Cholangiocarcinoma (ICC)	NCT01862315	Intrahepatic Ch... Peripheral Chol... Cholangiolar Ca... Cholangiocellul...	Floxuridine (FU... dexamethasone Gemcitabine Oxaliplatin MRI Research blood ...	21 Years -	Memorial Sloan Kettering Cancer Center
A Study to Determine Dose and Regimen of Durvalumab as Monotherapy or in Combination With Pomalidomide With or Without Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma	NCT02616640	Multiple Myelom...	Durvalumab Pomalidomide Dexamethasone	18 Years -	Celgene
Hepatic Arterial Infusion (HAI) With Floxuridine (FUDR) and Dexamethasone (Dex) Combined With Systemic Gemcitabine and Oxaliplatin in Patients With Unresectable Intrahepatic Cholangiocarcinoma (ICC)	NCT01862315	Intrahepatic Ch... Peripheral Chol... Cholangiolar Ca... Cholangiocellul...	Floxuridine (FU... dexamethasone Gemcitabine Oxaliplatin MRI Research blood ...	21 Years -	Memorial Sloan Kettering Cancer Center
A Study to Determine Dose and Regimen of Durvalumab as Monotherapy or in Combination With Pomalidomide With or Without Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma	NCT02616640	Multiple Myelom...	Durvalumab Pomalidomide Dexamethasone	18 Years -	Celgene
Salvage Treatment With Lenalidomide and Dexamethaosne (LEN-DEX) in Patients With Relapsed/Refractory Mantle Cell Lymphoma (MCL)	NCT00786851	MANTLE CELL LYM...	Lenalidomide an...	18 Years -	Fondazione Italiana Linfomi - ETS

Spots Global Cancer Trial Database for dexamethasone (dex)