Blood and Lymph Conditions

All Conditions

Neoplasms

Heart and Blood Diseases

Rare Diseases

Myeloproliferative Disorders

Polycythemia Vera

Polycythemia

Primary Myelofibrosis

Thrombocytosis

Thrombocythemia, Essential

Bone Marrow Diseases

Hematologic Diseases

Bone Marrow Neoplasms

Hematologic Neoplasms

Blood Platelet Disorders

Hemostatic Disorders

Blood Coagulation Disorders

Hemorrhagic Disorders

Chronic Myeloproliferative Disorders

Essential Thrombocythemia

Patients with Polycythemia vera (PV), essential thrombocythemia (ET) and primary myelofibrosis (PMF) will be recruited based on the WHO diagnostic criteria.

Exclusion Criteria

* younger than 18 years old.
* where the clinician/General Practitioner (GP) does not provide consent.
* incapable of giving informed consent.
* physically or cognitively incapable of completing the questionnaire.
* too ill to participate.

We will assess whether a pen (branded, non-branded or none), a £10 cheque and/or a charity branded trolley token will affect uptake rates in the study.

GP controls will be randomly selected and frequency matched to the distribution of cases by 5-year age band, geographic location (Belfast and Southampton) and gender.

The following patient groups will be excluded. Those:

* younger than 18 years old.
* where the clinician/GP does not provide consent.
* incapable of giving informed consent.
* physically or cognitively incapable of completing the questionnaire.
* too ill to participate.

We will assess whether a pen (branded, non-branded or none), a £10 cheque (at study completion) and/or a charity branded trolley token will affect uptake rates in the study.

Recruitment of 100 non-blood relative/friend controls will be undertaken by asking cases to pass on a flyer to up to 2 or 3 non-blood relatives/friends aged 18 years or older.

We will assess whether a pen (branded, non-branded or none) and/or a £10 cheque (at study completion) will affect uptake rates in the study. Only a limited number of trolley tokens were available so not assessed in this group.

Randomisation of branded pen, non-branded pen and no pen

Methodological pens

Randomisation of a £10 monetary reimbursement for expenses on completion of the study

Methodological compensation

Trolley tokens to be randomly assigned to half of cases and General Practice controls.

Methodological trolley tokens

Lesley A Anderson, PhD

There is a paucity of data on the aetiology of myeloproliferative neoplasms (MPNs). The investigators conducted a systematic review of the literature which identified several cohort and case-control studies that have investigated a wide range of potential medical, environmental and occupational risk factors. However, these studies have been limited by a wide variation in case definition and small sample sizes limiting the potential to detect modest risk differences between cases and controls. The research group propose an exploratory case-control study of 100 patients with classic MPNs and 200 controls to determine the optimal methods for roll out of this study to a multi-centred UK-based case-control study that will investigate the aetiology of MPN subtypes. The objectives of the study are to evaluate recruitment procedures, response rates and the development of a telephone administered questionnaire. The findings of this exploratory study will form the basis of a protocol for a large United Kingdom (UK)-wide case-control study of MPNs.

MPNs are a group of haematopoietic malignancies resulting from a transformed haematopietic progenitor cell. They are characterised by overproduction of mature functional blood cells. MPNs were historically termed myeloproliferative disorders and have undergone numerous amendments in classification. The 2008 World Health Organisation (WHO) classifies a number of related disorders as MPNs including polycythemia vera (PV), essential thrombocythemia (ET) and primary/idiopathic myelofibrosis (PMF)2. Reported incidence rates vary from 0.02 to 2.8 per 100,000 persons3-5 but are not well characterised with half of patients asymptomatic at diagnosis6. In Northern Ireland (NI) the prevalence of ET is reported to be 18 per 100,000 persons (by correspondence, Mary McMullin). PV and ET are indolent neoplasms with better prognosis (88% and 92% 3-year survival, respectively) compared to PMF which has a 63% 3-year survival in the United States5.

The main study objectives are to:

* Develop a telephone-based questionnaire to investigate potential risk factors associated with MPNs.
* Assess the reliability and validity of the study questionnaire.
* Determine which control group to investigate by investigating:

  * Response rates.
  * Representativeness of control groups.
* Assess recruitment procedures.
* Determine if offering reimbursement of expenses (£10 per person) encourages control participation and improved representativeness to the general population.

A case-control approach was chosen as it is the most cost-efficient method of obtaining information on the aetiology of rare diseases such as MPNs. A prospective cohort study would require participation from millions of individuals followed over a long period of time. A hospital-based approach was chosen over a population-based approach to ensure the study was more feasible and could be rolled out to a number of centres in the UK.

The disorders under investigation are:

* Polycythaemia vera
* Essential Thrombocythaemia
* Primary myelofibrosis

Initially there will be one site in Belfast, Northern Ireland and one in Southampton, England. Cases will be identified and recruited through Prof Mary Frances McMullin at the Belfast City Hospital (BCH), Belfast Health and Social Care Trust, Northern Ireland and Dr Andrew Duncombe, at the University Hospital Southampton NHS Foundation Trust (UHS), Southampton, England.

Following completion of the exploratory study it is planned that other sites across the UK will be invited to participate through the Clinical Research Network.

. CASE ASCERTAINMENT Recruitment will run over a 12 month period. It is estimated that at least 100 incident and prevalent MPN cases will be recruited from the two sites during this time frame; 50 from Belfast, NI and 50 from Southampton, England. The targeted distribution of cases projected as feasible is 40 PV, 40 ET and 20 PMF cases. Fewer PMF cases are expected as the incidence is lower than PV and ET. Both incident and prevalent cases will be recruited in the exploratory case-control study and the distribution of time since diagnosis evaluated. One of the main limitations of including prevalent cases is that risk factors may differ in those who survive for a long period after diagnosis compared to those who die soon after diagnosis. Since PV and ET have low mortality rates it is expected that this will not impact the evaluation of the aetiology of these conditions to a large extent. However for PMF, which has a higher mortality rate than PV or ET, cases will be recruited as close to diagnosis as possible.

Eligible cases will be identified by the two lead clinicians Prof McMullin (Belfast) and Dr Duncombe (Southampton) during attendance at their routine clinics. Prof McMullin and Dr Duncombe will ensure that potential cases meet the study inclusion criteria (section 2.5) and provide detailed information on the categorisation of the case (PV, ET, PMF), which diagnostic criteria have been met and the clinical history of the patient.

Patients will be invited to participate in the study by letter from their lead clinician with an information sheet. Non-respondents will be randomised to either receive a reminder letter or a telephone contact from their health care team.

The choice of control group is an important consideration in any case-control study. Controls recruited from the general population through General Practitioners, population registers, neighbourhood controls or random digit dialling are ideal at identifying a representative sample of the population from which the case population was identified. However, these groups often have low response rates and selection bias is inferably encountered. Other control groups such as friend, family or hospital controls have much higher response rates but the factors associated with friendship, family or being in hospital may mean that these groups are less representative of the general population. For the purposes of this study two control groups will be recruited; GP controls and non-blood relatives (including spouses) or friend controls. The study will investigate response rates, differences in study characteristics between control groups and generalisability to the population using population-based statistics.

2.8.1 GP Controls Within each study site 5 GPs, reflective of the geographic distribution of MPN cases, will be approached to facilitate the identification and recruitment of controls and for performing phlebotomy. Each practice will be offered £200 for participation in the study.

2.8.1.1 Northern Ireland Control Recruitment in Northern Ireland will be conducted with the help of the Northern Ireland Clinical Research Network (Primary Care) (NICRN (PC)) who work in partnership with GP practices to provide support, guidance and facilitate research. The NICRN nurses who work with practices hold a Confidentiality Agreement and honorary contract with the practice. Practices are supplied with a study file, which is kept in a secure location at the practice and contains the study protocol and all relevant study information including the completed Research Governance form and contact details of researchers and NICRN (PC) staff.

With prior arrangement and agreement with the practice partners the research nurse will make an appointment with the practice manager (PM) who will either facilitate practice staff to conduct a computer search to randomly select potential controls or supply the nurse with their own unique user name and password to do so. The search will be conducted using the practice computer system's inbuilt randomisation programme, based on a numbered list of age and gender-matched patients (approximating 2 per MPN case, calculated on the basis of an attrition rate of 40-50%). The GP will be asked to confirm the eligibility of each potential control patient prior to them receiving study information from the practice.

Study information will be mailed to eligible control patients from the practice on practice headed paper and with a letter, signed by the GP, inviting them to participate. In order to track patient replies, each envelope will have a unique code number written on the front. A patient tracker form with the unique code number written beside the relevant name on the list of control patients is kept in the practice study file to track responders and non-responders for follow up purposes. No patient identifiable data will be removed from the practice at any time.

Non-respondents will be randomised to either receive a reminder letter approx two weeks after the first mail shot or to have a telephone call from practice staff using the follow-up telephone transcript.

2.8.1.2 Southampton The research nurse in Southampton will work in partnership with GP practices to provide support, guidance and facilitate research. An honorary contract and confidentiality agreement will be arranged with the practices.. This will include the nurses NMC number and copies of GCP training certificates. Practices are supplied with a study file, which is kept in a secure location at the practice and contains the study protocol and all relevant study information including the completed Research Governance form and contact details of researchers and NICRN (PC) staff.

With prior arrangement and agreement with the practice partners the research nurse will make an appointment with the practice manager (PM) who will either facilitate practice staff to conduct a computer search to randomly select potential controls or supply the nurse with their own unique user name and password to do so. The search will be conducted using the practice computer system's inbuilt randomisation programme, based on a numbered list of age and gender-matched patients (approximating 2 per MPN case, calculated on the basis of an attrition rate of 40-50%). The GP will be asked to confirm the eligibility of each potential control patient prior to them receiving study information from the practice.

Study information will be mailed to eligible control patients from the practice on practice headed paper and with a letter, signed by the GP, inviting them to participate. In order to track patient replies, each envelope will have a unique code number written on the front. A patient tracker form with the unique code number written beside the relevant name on the list of control patients is kept in the practice study file to track responders and non-responders for follow up purposes. No patient identifiable data will be removed from the practice at any time.

Non-respondents will be randomised to either receive a reminder letter approx two weeks after the first mail shot or to have a telephone call from practice staff using the follow-up telephone transcript.

2.8.2 Relative/Friend Controls Recruitment of 100 non-blood relative/friend controls will be undertaken by asking cases to pass on a flyer to up to 2 or 3 non-blood relatives/friends aged 18 years or older. Controls meeting the exclusion, section 2.7, will not be eligible for participation. Controls will not be individually matched to cases but must reside in the study area (Belfast or Southampton). Blood relatives will not be eligible for participation. Partners or friends MPN cases attending outpatient appointments in Belfast City Hospital or UHS will also be approached to participate in the study as study flyers will be available. A reminder to follow-up with recruitment of non-blood relatives/controls will be undertaken at the time of telephone interview with the cases. Those interested in participating in the study can contact the study team for the information sheet, consent form and other documentation by completing the tear off contact details strip on the flyer and posting (in the FREEPOST envelope that will be attached to the flyer) to the study team or by telephone or e-mail.

INFORMED CONSENT All cases and controls will be contacted by letter with a patient information leaflet, a consent form, patient contact form and work/residence history calendar. A pen will be included in the envelope in addition to a MPD Voice charity information sheet and a trolley token (for 50% of cases and controls). The number of subjects who refuse to participate will be documented. Subjects who refuse to participate at telephone contact will be asked whether they are willing to answer a short questionnaire to assess the representativeness of the recruited subjects. Subjects will be given the opportunity to withdraw from the study at any time however the information provided up to that point will be retained and used within the study. Subjects will be asked for verbal consent at time of telephone interview to have the interview recorded both before and after (if agreeable) the recording device is activated.

Venous blood sample (up to 12 ml) - whole blood, DNA Saliva (2ml) Dried Blood spots (500 µl) Toe-nails (2 great toe-nail clippings)

Myeloproliferative Neoplasms: an In-depth Case-control Study

Researchers can contact the study lead (Dr Anderson) to request a data access form. Once a data access form has been completed it will be reviewed by the study team and a decision made. If sharing of data has been agreed by the study team the contracts department and legal teams will review the proposed sharing of data to ensure that it meets with international standards.

* Difference in participation rates in those receiving:
* vs. not receiving a pen at initial contact.
* vs. not receiving a trolley token at initial contact.
* vs. not receiving a monetary incentive at initial contact.
* a MOSAICC pen vs. a non-branded pen following second contact.
* vs. not receiving a trolley token following second contact.
* a MOSAICC branded Pen +/or trolley token alone vs no non-monetary incentive following a second invite.
* a MOSAICC branded Pen +/or trolley token alone vs no incentive following a second invite.
* a MOSAICC branded Pen +/or trolley token alone vs pen/no pen \&/or money following a second invite (branded vs unbranded incentive)
* 0/1 of these incentives vs. receiving 2/3 incentives following a second invite.
* Difference in proportion of patients completing study elements comparing:
* 0/1 vs 2/3 incentives.
* those receiving pre vs post invitation incentives.

University Hospital Southampton NHS Foundation Trust

University of Manchester

Western Australian Institute for Medical Research

Mayo Clinic

Queen's University, Belfast

Chief Investigator

Adverse Events were not collected/assessed

Patients with Polycythemia vera (PV), essential thrombocythemia (ET) and primary myelofibrosis (PMF) will be recruited based on the WHO diagnostic criteria.

Exclusion Criteria

* younger than 18 years old.
* where the clinician/General Practitioner (GP) does not provide consent.
* incapable of giving informed consent.
* physically or cognitively incapable of completing the questionnaire.
* too ill to participate.

Methodological pens: Randomisation of branded pen, non-branded pen and no pen

Methodological compensation: Randomisation of a £10 monetary reimbursement for expenses on completion of the study

Methodological trolley tokens: Trolley tokens to be randomly assigned to half of cases and General Practice controls.

Myeloproliferative Neoplasm Case

For each MPN case one GP control will be randomly selected and frequency matched to the distribution of cases by 5-year age band, geographic location (Belfast and Southampton) and gender.

The following patient groups will be excluded. Those:

* younger than 18 years old.
* where the clinician/GP does not provide consent.
* incapable of giving informed consent.
* physically or cognitively incapable of completing the questionnaire.
* too ill to participate. The WHO performance evaluation scale will be used at the stage of participant identification. Only those scoring 0-3 will be considered eligible for inclusion in the study. Those scoring 3 are described as "Symptomatic \>50% in bed but not bedbound".

General Practice Control

Recruitment of 100 non-blood relative/friend controls will be undertaken by asking cases to pass on a flyer to up to 2 or 3 non-blood relatives/friends aged 18 years or older.

Methodological pens: Randomisation of branded pen, non-branded pen and no pen

Methodological compensation: Randomisation of a £10 monetary reimbursement for expenses on completion of the study

Non-blood Relative or Family Control

The letters inviting participants to participate in the study were randomised to contain:

* a branded pen, an unbranded pen or no pen
* a trolley token
* Information in the study information leaflet that £10 compensation cheque would be provided upon completion and details in the letter that compensation would be provided vs no mention of compensation in the information booklet or invitation letter.

The letters inviting participants to participate in the study were randomised to contain:

* a branded pen, an unbranded pen or no pen
* Information in the study information leaflet that £10 compensation cheque would be provided upon completion and details in the letter that compensation would be provided vs no mention of compensation in the information booklet or invitation letter.

Non-blood Relative Family Control

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United Kingdom

Region of Enrollment

Dr Lesley Anderson

No. of Participants who didn't receive an incentive

No. of participants who got pen - INITIAL CONTACT

No. participants got TrolleyToken- INITIAL CONTACT

No. participants got compensation -INITIAL CONTACT

No. who got Mosaicc pen- INITIAL CONTACT

No. who got Normal pen-INITIAL CONTACT

No. who got Pre-incentive (pen and/or trolley token) only- INITIAL CONTACT

No. who got compensation only- INITIAL CONTACT

No. who got pre & post incentive e.g. pen, trolley token and compensation - INITIAL CONTACT

No. of participants who got 0 or 1 incentive- INITIAL CONTACT

No of participants 2or 3 incentives(F/F controls could only receive a max of 2 incentives) - INITIAL

No who participated after the second invite

No of participants after second invite who initially received a MOSAICC pen

No of participants after second invite who initially received a Normal pen

No of participants after second invite who initially received a Trolley token

For each MPN case one GP control will be randomly selected and frequency matched to the distribution of cases by 5-year age band, geographic location (Belfast and Southampton) and gender.

The following patient groups will be excluded. Those:

* younger than 18 years old.
* where the clinician/GP does not provide consent.
* incapable of giving informed consent.
* physically or cognitively incapable of completing the questionnaire.
* too ill to participate. The WHO performance evaluation scale will be used at the stage of participant identification. Only those scoring 0-3 will be considered eligible for inclusion in the study. Those scoring 3 are described as "Symptomatic \>50% in bed but not bedbound".

Methodological pens: Randomisation of branded pen, non-branded pen and no pen

Methodological compensation: Randomisation of a £10 monetary reimbursement for expenses on completion of the study

Methodological trolley tokens: Trolley tokens to be randomly assigned to half

Influence of Pre- and Post- Incentives on Participation Rates.

Overall Study

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Antineoplastic Agents

All Drugs and Chemicals

Decitabine

Antimetabolites

Enzyme Inhibitors

Decitabine 20 mg/m2 by vein daily for 5 days.

Decitabine 20 mg/m2 by vein daily for 10 days.

20 mg/m2 by vein daily for either 5 or 10 days.

Farhad Ravandi-Kashani, MD

The goal of this clinical research study is to compare how well 2 different dosing schedules of decitabine may help control AML.

Decitabine is designed to damage the DNA (the genetic material) of cells, which may cause cancer cells to die.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to 1 of 2 dose levels of decitabine based on when you join this study. If you are among the first 20 participants, you will have an equal chance of being in either group. If you enroll after that, you will have an increasingly higher chance (51-100%) of being assigned to the group that had better results, depending on how much better that treatment arm is.

Study Drug Administration:

Each cycle is about 4-8 weeks, depending on the doctor's decision. In this study you will receive induction therapy to try to control the disease and cause remission (this is when tests and/or the doctor cannot find signs of the disease).

If you are in Group 1, you will receive decitabine by vein over about 1 hour for 5 days.

If you are in Group 2, you will receive decitabine by vein over about 1 hour for 10 days.

If the disease is in remission, you may receive more cycles (called maintenance) to help keep the disease under control. If you are in Group 2, you will receive 5 day dosing during maintenance, or when the doctor thinks it is in your best interest.

Your dose schedule or dose level may be changed if the doctor feels it is in your best interest.

Study Visits:

The following tests and procedures will be performed:

* Blood (about 2-3 teaspoons) will be drawn 1-2 times weekly for first cycle, then every 2-4 weeks after that. After the 6th cycle or sooner if the doctor decides, this blood draw will be performed only 1 time per cycle.
* Every 1-3 cycles, you will have a bone marrow aspiration/biopsy to check the status of the disease. Blood (about 2-3 teaspoons) may also be drawn for genetic testing if the disease is in remission and the doctor thinks it is needed.

Length of Treatment:

You may continue taking the study drug for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation in this study will be over after the follow-up phone calls.

Follow-Up:

After you stop the study treatment, you will be called by phone twice a year and asked how you are feeling. The phone calls should last about 5 minutes each time.

This is an investigational study. Decitabine is FDA approved and commercially available for the treatment of myelodysplastic syndrome (MDS). Its use to treat AML is investigational.

Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.

Decitabine for Older or Unfit Patients With Acute Myeloid Leukemia (AML)

A Randomized Phase II Study of Two Schedules of Decitabine for Frontline Therapy of Older or Unfit Patients With Acute Myeloid Leukemia (AML)

Response is defined as Complete Response (CR) + Partial Remission (PR) + Complete Remission with incomplete recovery (CRi) + Clinical Benefit. CR is the normalization of the peripheral blood and bone marrow with \</= 5% bone marrow blasts, a peripheral blood granulocyte count \>/= (1.0 x 10\^9/L, and a platelet count \>/= 100 x 10\^9/L). PR is the same as CR except for the presence of 6-15% marrow blasts, or 50% reduction if \<15% at start of treatment. CRi meets all criteria for CR except for platelet recovery to \>100 x 10\^9/L and/or granulocyte count \> (1.0 x 10\^9/L). Clinical benefit is platelets increase by 50% and to above 30 x 10\^9/L untransfused (if lower than that pretherapy); or granulocytes increase by 100% and to above 10\^9/L (if lower than that pre-therapy); or hemoglobin increase by 2 g/dl; or transfusion independent; or splenomegaly reduction by \> 50%; or monocytosis reduction by \> 50% if pretreatment \> 5 x 109/L.

Time from date of treatment start until date of death due to any cause or last Follow-up.

The date of response to date of loss of response or last follow-up. Response is defined as Complete Response (CR) + Partial Remission (PR) + Complete Remission with incomplete recovery (CRi) + Clinical Benefit. CR is the normalization of the peripheral blood and bone marrow with \</= 5% bone marrow blasts, a peripheral blood granulocyte count \>/= (1.0 x 10\^9/L, and a platelet count \>/= 100 x 10\^9/L). PR is the same as CR except for the presence of 6-15% marrow blasts, or 50% reduction if \<15% at start of treatment. CRi meets all criteria for CR except for platelet recovery to \>100 x 10\^9/L and/or granulocyte count \> (1.0 x 10\^9/L). Clinical benefit is platelets increase by 50% and to above 30 x 10\^9/L untransfused (if lower than that pretherapy); or granulocytes increase by 100% and to above 10\^9/L (if lower than that pre-therapy); or hemoglobin increase by 2 g/dl; or transfusion independent; or splenomegaly reduction by \> 50%; or monocytosis reduction by \> 50% if pretreatment

M.D. Anderson Cancer Center

Decitabine 20 mg/m2 by vein daily for 5 days.

Decitabine: 20 mg/m2 by vein daily for either 5 or 10 days.

Decitabine - 5 Day Regimen

Decitabine 20 mg/m2 by vein daily for 10 days.

Decitabine: 20 mg/m2 by vein daily for either 5 or 10 days.

Decitabine - 10 Day Regimen

Race (NIH/OMB)

United States

Farhad Ravandi-Kashani MD/Professor

Participants With a Response

Overall Survival

Response Duration

Symptoms and General Pathology

Digestive System Diseases

Carcinoma

Adenocarcinoma

Neoplasm Metastasis

Liver Neoplasms

Disease Progression

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neoplastic Processes

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Micronutrients

Hematinics

Irinotecan

Dexamethasone

Cetuximab

Leucovorin

Fluorouracil

Oxaliplatin

Dexamethasone acetate

Liver Extracts

Panitumumab

Floxuridine

Topoisomerase I Inhibitors

Antineoplastic Agents, Immunological

HAIP chemotherapy + Systemic chemotherapy

implanted Medtronic SynchroMed II Pump with codman 3000 Constant Flow Pump Catheter

Codman 3000 constant flow pump catheter

HAIP will be filled with mixture of Floxuridine and Dexamethasone. Pump will perfuse drugs to liver for 14 days. Floxuridine (0.12 mg/kg X pump volume X pump flow rate),Dexamethasone (1 mg/day X pump volume (30) X pump flow rate)

FUDR-Dex

2000 mg/m2, IV 46-hour infusion of 5-Fluorouracil + 400 mg/m2, IV of Leucovorin

HAIP installation

cetuximab

implanted Medtronic SynchroMed II Pump with Codman 3000 Constant Flow Pump Catheter

Medtronic SynchroMed II Pump

Kathleen M Smith, R.N.

Jonathan M Hernandez, M.D.

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

Background:

Many people with colorectal cancer get liver metastases. Standard treatment for this is a combination of chemotherapy drugs. Directing the chemotherapy to the liver may be effective. A device that does this a pump that delivers drugs over 2 weeks at constant rate into the hepatic artery. The person s body temperature causes the drug to flow from the pump. Researchers want to see if this helps people with colorectal metastases to the liver.

Objective:

To study the effectiveness of a hepatic artery infusion pump at treating colorectal metastases to the liver.

Eligibility:

Adults at least 18 years old with colorectal metastases to the liver

Design:

Participants will be screened with:

Medical history

Physical exam

Heart, blood, and urine tests

Scans

Participants will stay in the hospital a few days. A small plastic tube (catheter) will be inserted in an artery into the liver. The catheter will be attached to the pump. That will lie under the skin on the abdomen. It will be small and participants will be able to feel it.

Participants will get treatment in 28-day cycles.

Every Day 1, they will have physical exam, symptom review, and blood tests.

Every 2 weeks, they will come to the clinic to get chemotherapy by a catheter or port.

Every 12 weeks, they will have a scan.

Tissue samples may be taken during the study.

When they finish the drug, participants may have the pump removed. They will repeat the Day 1 tests. They will be called every 6 months to see how they are doing.

Background:

* Nearly 60% of patients with colorectal cancers will develop liver metastases over the course of their disease.
* Of patients with metastatic colorectal cancer, the liver will be the sole site of recurrence or the survival-limiting site of disease for 20%.
* Liver directed therapy, which has taken many forms over the last several decades, is a potential means to prolong survival for properly selected patients and delay progression at that site.
* Hepatic artery infusion of floxuridine (FUDR) via an implantable hepatic artery infusion pump (HAIP) induces objective clinical response rates of nearly 50% in heavily pre-treated patients with metastatic colorectal cancer to the liver.
* The identification of patients likely to respond to HAIP and those likely to suffer pumprelated adverse events is currently unknown, and has limited the wide-spread adoption of this otherwise well tolerated intervention.

Objective:

* To assess the safety of hepatic artery infusion therapy using the Medtronic pump with the Codman catheter.
* To determine the response rate in patients with unresectable metastatic colorectal cancer treated with HAIP chemotherapy as measured by RECIST.

Eligibility:

* Histologically or cytologically confirmed colorectal adenocarcinoma metastatic to the liver.
* Patients with liver metastases not amenable to resection to No Evidence of Disease (NED) in one stage.
* Patients must have received systemic chemotherapy.
* Age greater than or equal to 18 years.

Design:

- Single arm, Phase II study of HAIP chemotherapy.

Hepatic Artery Infusion Pump Chemotherapy With Floxuridine and Dexamethasone in Combination With Systemic Chemotherapy for Patients With Colorectal Cancer Metastatic to the Liver

A Single-Arm Phase II Study of Hepatic Artery Infusion Pump Chemotherapy With Floxuridine and Dexamethasone in Combination With Systemic Chemotherapy for Patients With Colorectal Cancer Metastatic to the Liver

.All IPD recorded in the medical record will be shared with intramural investigators upon request.

The fraction of patients who experience a PR or CR using the study treatment

Median amount of time subject survives after therapy

The fraction of patients whose tumors in liver shrunk after therapy

The fraction of patients whose tumors outside liver shrunk after therapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Myeloproliferative Neoplasms: an In-depth Case-control Study	NCT01831635	Polycythemia Ve... Essential Throm... Primary Myelofi...	Methodological ... Methodological ... Methodological ...	18 Years -	Queen's University, Belfast
Decitabine for Older or Unfit Patients With Acute Myeloid Leukemia (AML)	NCT01786343	Leukemia	Decitabine	60 Years -	M.D. Anderson Cancer Center
Myeloproliferative Neoplasms: an In-depth Case-control Study	NCT01831635	Polycythemia Ve... Essential Throm... Primary Myelofi...	Methodological ... Methodological ... Methodological ...	18 Years -	Queen's University, Belfast
Hepatic Artery Infusion Pump Chemotherapy With Floxuridine and Dexamethasone in Combination With Systemic Chemotherapy for Patients With Colorectal Cancer Metastatic to the Liver	NCT03366155	Colorectal Canc... Liver Metastase... Colorectal Aden... Colorectal Canc... Colorectal Carc...	Codman 3000 con... Panitumumab FUDR-Dex Oxaliplatin 5FU Irinotecan HAIP installati... cetuximab Medtronic Synch...	18 Years -	National Institutes of Health Clinical Center (CC)
Decitabine for Older or Unfit Patients With Acute Myeloid Leukemia (AML)	NCT01786343	Leukemia	Decitabine	60 Years -	M.D. Anderson Cancer Center
Hepatic Artery Infusion Pump Chemotherapy With Floxuridine and Dexamethasone in Combination With Systemic Chemotherapy for Patients With Colorectal Cancer Metastatic to the Liver	NCT03366155	Colorectal Canc... Liver Metastase... Colorectal Aden... Colorectal Canc... Colorectal Carc...	Codman 3000 con... Panitumumab FUDR-Dex Oxaliplatin 5FU Irinotecan HAIP installati... cetuximab Medtronic Synch...	18 Years -	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for response rates