I WILL NOT POST TO THIS BLOG ANY MORE:

IF YOU WANT ANSWERES TO YOUR COMMENTS PLEASE GO TO THE URL LISTED BELOW.

I have another blog that I have been posting to for the last three years.  It has much more information on it.  I am sorry but it has become a chore to attempt to post information to both blogs.  Therefore, I have decided to quit posting to this blog and post exclusively to my older blog.  The URL for my other blog is:

http://multiplesclerosis.blogharbor.comPlease enter this new blog into your favourites.

I usually post anywhere between 2 and 7 times a day to this other blog.

Bonnie

 

 

 

 

High-Dose Immunosuppression and Autologous Transplantation for Multiple Sclerosis (HALT MS) Study

 

This study is currently recruiting participants.

 

Verified by National Institute of Allergy and Infectious Diseases (NIAID), January 2009

First Received: February 7, 2006   Last Updated: March 3, 2009  

 

History of Changes

Sponsors and Collaborators:

National Institute of Allergy and Infectious Diseases (NIAID)
Immune Tolerance Network

Information provided by:

National Institute of Allergy and Infectious Diseases (NIAID)

ClinicalTrials.gov Identifier:

NCT00288626

Purpose

The purpose of this study is to determine the effectiveness of a new treatment for multiple sclerosis (MS), a serious disease in which the immune system attacks the brain and spinal cord. MS can be progressive and severe and lead to significant disability. The study treatment involves the use of high-dose chemotherapeutic drugs to suppress the immune system. The participant’s own (autologous) blood-forming (hematopoietic, CD34+) stem cells are collected before the chemotherapy is given, and then transplanted back into the body following treatment. Transplantation of autologous hematopoietic stem cells is required to prevent very prolonged periods of low blood cell counts after the high-dose chemotherapy.

 

Condition

Intervention

Phase

 

 

Multiple Sclerosis

 

Drug: Granulocyte-colony stimulating factor (G-CSF) and prednisone
Drug: Carmustine, etoposide, cytarabine, and melphalan (BEAM)
Procedure: Autologous hematopoietic stem cell transplant

 

Phase II

 

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Prednisone Cytarabine hydrochloride Etoposide Etoposide phosphate Granulocyte colony-stimulating factor Cytarabine Melphalan Carmustine Sarcolysin Melphalan hydrochloride

U.S. FDA Resources

 

 

Study Type:

Interventional

 

Study Design:

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

 

Official Title:

A Phase II Study of High-Dose Immunosuppressive Therapy (HDIT) Using Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) and Thymoglobulin, and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT) for the Treatment of Poor Prognosis Multiple Sclerosis

 

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

 

 

Primary Outcome Measures:

 

·      Time to treatment failure [ Time Frame: During the 5 years after transplant ] [ Designated as safety issue: No ]

 

Estimated Enrollment:

30

 

Study Start Date:

July 2006, still recruiting

 

Estimated Study Completion Date:

January 2015

 

Estimated Primary Completion Date:

September 2014 (Final data collection date for primary outcome measure)

 

 

Arms

 

Assigned Interventions

 

1: Experimental

 

Drug: Granulocyte-colony stimulating factor (G-CSF) and prednisone

Growth factor regimen; occurs at study entry

Drug: Carmustine, etoposide, cytarabine, and melphalan (BEAM)

High-dose chemotherapy; occurs seven or more days following collection of autologous graft

Procedure: Autologous hematopoietic stem cell transplant

Occurs after growth factor regimen and collection of autologous graft

 

Detailed Description:

MS is a chronic autoimmune disease of the central nervous system in which myelin, the protective coat that surrounds nerve cells, is damaged or destroyed by autoimmune T cells and macrophages, leading to an eventual loss of neurologic function. In a pilot study in Europe using high-dose chemotherapy, it was observed that 18 of 19 MS patients stabilized or improved clinically, and only one patient showed a new lesion on magnetic resonance imaging (MRI) of the brain at 4.5 years after treatment. Improvement was seen in quality-of-life assessments.

In ITN033AI, high-dose chemotherapy with autologous CD34-selected hematopoietic cell transplantation will be given to confirm the results from the pilot study and to offer therapy to patients with early MS and a poor prognosis. Research studies will be performed in addition to clinical assessments to better understand the effect of the treatment on the activity of MS. High-dose chemotherapy will be used to deplete autoreactive immune cells. These regimens also deplete the bone marrow, the source of blood-forming CD34+ stem cells which causes very low blood counts. Therefore, the participant’s autologous CD34+ hematopoietic stem cells will be collected before high dose immunosuppressive therapy is given and then returned as a transplant post-chemotherapy. Patients will be followed closely after the autologous transplantation since they will be at risk for infections after treatment.

At the beginning of the study, participants will undergo a number of screening and baseline procedures, including a physical exam, blood collection, MS-confirming neurology exams and questionnaires, and MRI procedures. Participants will be given prednisone and granulocyte-colony stimulating factor (G-CSF) to mobilize CD34+ hematopoietic stem cells from the bone marrow into the peripheral blood. When the peripheral blood CD34+ cell count reaches 20,000 cells/ml or greater, these cells will be collected by leukapheresis. In this process, a catheter is placed into a large blood vessel, peripheral blood is withdrawn, and a high speed sedimentation (leukapheresis) device is used to separate and retain the cells required for autologous transplantation. Other blood cells are then returned to the participant’s body. In the laboratory, the CD34+ hematopoietic stem cell graft will be selected and prepared from the leukapheresis collection, and stored until needed for transplant. Seven or more days following the collection of their autologous graft, participants will be hospitalized and receive high-dose chemotherapy consisting of carmustine, etoposide, cytarabine, and melphalan (BEAM) and thymoglobulin. This is followed by transplantation of the autologous hematopoietic cell graft. Participants will remain in the hospital for observation during recovery of their peripheral blood cell counts, as described in the protocol. Participants will receive G-CSF and blood transfusions, if needed, and will be monitored for infections. Following discharge from the hospital, eight study visits will occur over sixty months (five years).

During these visits, participants will undergo blood and urine collection, MRI studies, leukapheresis, and MS neurology exams and will complete questionnaires.

 

 

Eligibility

 

Ages Eligible for Study:  

 

18 Years to 60 Years

 

Genders Eligible for Study:

  

Both

 

Accepts Healthy Volunteers:

 

No

Criteria

Inclusion Criteria:

·      Diagnosis of relapsing-remitting or progressive-relapsing multiple sclerosis for less than 15 years using McDonald Criteria. More information on this criterion can be found in the protocol.

·      Score between 3.0 and 5.5 on the Expanded Disability Status Scale (EDSS)

·      T2 abnormalities on brain MRI consistent with MS

·      Two or more relapses in 18 months time on interferon (IFN), glatiramer acetate (GA), natalizumab or cytotoxic therapy with EDSS increase of 1.0 or greater for participants with EDSS at screening of 3.0 to 3.5 (0.5 or greater for participants with EDSS at screening of 4.0 to 5.5) sustained at least 4 weeks after at least one of these relapses OR one relapse on IFN, GA, natalizumab or cytotoxic therapy with EDSS increase of 1.5 or greater (1.0 for subjects with EDSS at screening of 5.5) sustained at least 4 weeks, together with MRI changes consistent with poor prognosis. More information on this criterion can be found in the protocol.

·      On IFN or GA for at least 6 months before the relapses occur that are counted to satisfy previous inclusion criterion OR have received adequate doses of natalizumab or cytotoxic therapy on a treatment schedule before the relapses occur that are counted to satisfy previous inclusion criterion.

·      Approval by an MS Review Panel to participate in the study. More information on this criterion can be found in the protocol.

·      In good clinical condition with adequate organ function and without coexisting medical problems that would increase the risk to the participant

·      Willing to use acceptable methods of contraception

·      Willing and able to comply with all study requirements

·      Willing to accept and comprehend irreversible sterility as side effect of therapy

Exclusion Criteria:

·      Primary progressive MS

·      Secondary progressive MS without relapses (i.e., progression without exacerbations or relapses) for 12 or more months

·      Neuromyelitis optica, a disease similar to MS

·      Initiation of new immunosuppressant treatment after the participant becomes eligible for the protocol or continuance of immunosuppressant drugs after the participant is screened for the protocol. Treatment with IFN, GA, or corticosteroids is permitted after the participant becomes eligible for the protocol.

·      Lapse of greater than 6 months between the time a participant is eligible for the protocol and initiation of protocol treatment except when judged acceptable by the MS Review Panel

·      Prior treatment with investigational immunosuppressive agents within 3 months of study eligibility

·      Positive baseline plasma and CSF testing for JC virus or a brain MRI that has changes consistent with a diagnosis of progressive multifocal encephalopathy (PML).

·      History of cytopenia consistent with the diagnosis of myelodysplastic syndrome (MDS)

·      Active hepatitis B or C infection, cirrhosis, or HIV infection

·      Uncontrolled diabetes mellitus

·      Uncontrolled viral, fungal, or bacterial infection. Patients with asymptomatic bacteriuria are not excluded.

·      Any illness that would jeopardize the ability to tolerate aggressive chemotherapy

·      Prior history of malignancy, except localized basal cell or squamous skin cancer. Other malignancies for which the subject is judged cured by the administered therapy will be considered on an individual basis.

·      Hypersensitivity to mouse, rabbit, or Escherichia coli-derived proteins or to iron compounds/medications

·      Metallic objects implanted in the body that would affect MRI exams

·      Psychiatric illness, mental deficiency, or cognitive dysfunction

·      Pregnancy

·       

Contacts and Locations

 

Please refer to this study by its ClinicalTrials.gov identifier: NCT00288626

Locations

 

United States, Ohio

Ohio State University School of Medicine

 

Recruiting

 

Columbus, Ohio, United States, 43210

Contact: Lisa Hafer     614-293-7877     hafer.15@osu.edu    

Principal Investigator: Michael K. Racke, MD            

Principal Investigator: Steven M. Devine, MD            

 

United States, Texas

 

M.D. Anderson Cancer Center; Transplant site, please contact Baylor College of Medicine

 

Recruiting

 

Houston, Texas, United States, 77230-1402

Contact: Uday Popat, MD     713-745-3055     upopat@mdanderson.org    

Principal Investigator: Uday Popat, MD            

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contact: Semahat Eiswirth, RN     713-798-6059     sparilti@bcm.edu    

Contact: George J. Hutton, MD     713-798-8170     ghutton@bcm.tmc.edu    

Principal Investigator: George J. Hutton, MD            

United States, Washington

Fred Hutchinson Cancer Research Center

 

Recruiting

 

Seattle, Washington, United States, 98109-1024

Contact: Bernie McLaughlin, RN     206-667-4916     bmclaugh@fhcrc.org    

Principal Investigator: James Bowen, MD            

Principal Investigator: Richard Nash, MD            

Principal Investigator: George H. Kraft, MD

 

           

Sponsors and Collaborators

 

National Institute of Allergy and Infectious Diseases (NIAID)

Immune Tolerance Network

 

Investigators

 

Study Chair:

Richard A. Nash, MD

Fred Hutchinson Cancer Research Center, Clinical Research Division, University of Washington

Study Chair:

James D. Bowen, MD

Multiple Sclerosis Center, Swedish Neuroscience Institute, Seattle, Washington

Study Chair:

George H. Kraft, MD

Departments of Neurology and Rehabilitation Medicine, University of Washington

Study Chair:

George J. Hutton, MD

The Maxine Messinger Multiple Sclerosis Clinic, The Methodist Hospital, Baylor College of Medicine

Study Chair:

Uday Popat, MD

Department of Blood and Marrow Transplantation, University of Texas, M.D. Anderson Cancer Center

Study Chair:

Michael K. Racke, MD

Department of Neurology, Ohio State University Medical Center

Study Chair:

Steven M. Devine, MD

Department of Hematology and Oncology, Ohio State University Medical Center

 

 

More Information

Additional Information:

Click here for the Immune Tolerance Network Web site 

Publications:

Fassas A, Nash R. Stem cell transplantation for autoimmune disorders. Multiple sclerosis. Best Pract Res Clin Haematol. 2004 Jun;17(2):247-62. Review.

Muraro PA, Douek DC. Renewing the T cell repertoire to arrest autoimmune aggression. Trends Immunol. 2006 Jan 4; [Epub ahead of print]

Muraro PA, Douek DC, Packer A, Chung K, Guenaga FJ, Cassiani-Ingoni R, Campbell C, Memon S, Nagle JW, Hakim FT, Gress RE, McFarland HF, Burt RK, Martin R. Thymic output generates a new and diverse TCR repertoire after autologous stem cell transplantation in multiple sclerosis patients. J Exp Med. 2005 Mar 7;201(5):805-16. Epub 2005 Feb 28.

Saccardi R, Mancardi GL, Solari A, Bosi A, Bruzzi P, Di Bartolomeo P, Donelli A, Filippi M, Guerrasio A, Gualandi F, La Nasa G, Murialdo A, Pagliai F, Papineschi F, Scappini B, Marmont AM. Autologous HSCT for severe progressive multiple sclerosis in a multicenter trial: impact on disease activity and quality of life. Blood. 2005 Mar 15;105(6):2601-7. Epub 2004 Nov 16.

Tyndall A, Saccardi R. Haematopoietic stem cell transplantation in the treatment of severe autoimmune disease: results from phase I/II studies, prospective randomized trials and future directions. Clin Exp Immunol. 2005 Jul;141(1):1-9. Review.

Mancardi G, Saccardi R. Autologous haematopoietic stem-cell transplantation in multiple sclerosis. Lancet Neurol. 2008 Jul;7(7):626-36. Review.

 

Responsible Party:

DAIT/NIAID ( Associate Director, Clinical Research Program )

Study ID Numbers:

DAIT ITN033AI, DAIT SCMS2

Study First Received:

February 7, 2006

Last Updated:

March 3, 2009

ClinicalTrials.gov Identifier:

NCT00288626     History of Changes

Health Authority:

United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Hematopoietic Stem Cell Transplantation
Immunosuppressive Agents

Study placed in the following topic categories:

Antimetabolites
Prednisone
Melphalan
Autoimmune Diseases
Demyelinating Diseases
Carmustine
Sclerosis
Antiviral Agents
Immunosuppressive Agents
Etoposide phosphate

Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Mitogens
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Alkylating Agents
Etoposide
Autoimmune Diseases of the Nervous System
Cytarabine

Additional relevant MeSH terms:

Antimetabolites
Melphalan
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Pathologic Processes
Multiple Sclerosis
Therapeutic Uses
Etoposide
Alkylating Agents
Cytarabine

Autoimmune Diseases of the Nervous System
Autoimmune Diseases
Immune System Diseases
Demyelinating Diseases
Carmustine
Nervous System Diseases
Sclerosis
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Myeloablative Agonists
Demyelinating Autoimmune Diseases, CNS
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 06, 2009

 

Tysabri & PML In MS Patients

 

Helen Yates, Chief Executive of the Multiple Sclerosis Resource Centre (MSRC) said: “We truly hope that the research leads to a treatment for this very worrying and potentially life threatening condition. It is important that people affected by MS that are undergoing treatment with Tysabri have as much reassurance as possible about the potential side effects and the ability to treat them should they arise.” As reported by The Irish Times: A possible treatment for a potentially fatal side effect of multiple sclerosis therapy, Tysabri, and other immune-modulating drugs is currently under investigation. Biogen Idec, Elan’s partner in the development and sale of Tysabri, is testing the efficacy of a malaria pill developed during the Vietnam war in treating progressive multifocal leukoencephalopathy (PML), the brain infection that has been tied to use of Tysabri, according to Al Sandrock, Biogen’s head of neurology research. Tysabri was pulled from the market in 2005 after three PML cases were reported. It was reintroduced in 2006 when US regulators said the medication’s effectiveness, twice that of other MS drugs, outweighed its risks. However, the threat of PML has affected sales of the treatment which, although a successful drug in commercial terms, is well short of the figures initially expected. The companies have reported five new PML cases since July 2008, reigniting concerns of patients who believe a safer Tysabri would be their best treatment option, said John Richert of the US National Multiple Sclerosis Society. Tysabri, a laboratory-engineered antibody, is designed to suppress the immune attack that leads to MS. PML occurs when a common germ, called JC virus, mutates, evades the body’s immune defences and penetrates the brain, causing irreversible damage. Biogen has been seeking a PML treatment since 2005, screening about 2,000 compounds known to fight brain infections. The drug showing the most promise in laboratory tests was the commonly used malaria pill, mefloquine. A clinical trial is now testing mefloquine in 40 patients with PML from any cause, whether drug-related or from HIV. The goal is to see whether mefloquine, sold by Roche Holding under the name Lariam, can treat PML when it occurs. The trial is expected to be completed by the end of the year. Source Multiple Sclerosis Resource Centre Main News Category: Multiple Sclerosis Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional. For more information, please read our terms and conditions. 29 Mar 2009

Dear Readers,

 

 

 

I would like to explain to you why I haven’t posted very many articles on my blog for the past few months.

 

 

 

I had a relapse in October 2008 and just could not seem to get my sluggish brain to do any research with any amount of understanding.  Then came Christmas and all the hubbub over that.  Our family has decided to make our Christmas presents from now on, and only buy for the little guy in our life.  Making presents sounds like a great idea; no commercialism, no great expenditure, creative, etc.  But, as I didn’t start to make my presents early enough (mostly because I couldn’t think of what to make for everyone) I was up to the wire in finishing my creations.  I vowed that I would start sewing for everyone earlier this year.  Ha, I haven’t started yet for this year.

 

 

 

Shortly after Christmas I slipped into a depression.  Depression has always been a struggle for me since I am bi-polar (manic depressive).  Shortly after I swam up from the depths of depression, my husband was hospitalized with a very severe form of pneumonia.  He was hospitalized for a little over a week.  When he went for his check-up, after that episode.  His doctor noticed that his leg was swollen, red, and hot.  Of course, he was sent for x-rays and an ultra sound.  The radiologist appeared in the room and said that he had blood clots from his groin to his ankle.  My husband was duly sent to the emergency at our local hospital.  After many hours in that place he was admitted and put on warfarin.  The specialist said that his pneumonia was caused by a clot breaking away and settling in his lung.  He could have died.  He has not be able to work since he was in with pneumonia and will not be able to work for another 3 months, that will be 6 months in total.  His leg is still quite red and swollen.

 

 

 

After my husband’s illness sort of settled down, my daughter became ill.  She has had to get monthly blood work done for several months because of some medication she is taking.  Her doctor commented on the fact that her white blood count was up and down, sometimes being very high.  Other blood counts were out off kilter and never the same twice.  That doctor did not seem all that concerned about these inconsistencies in her blood.  Not long after she started going to a different doctor he became very concerned about these inconsistencies.  He has referred her to various specialists.

 

 

 

My daughter has been without energy and sleeps more than is normal for months now.  She is always cold most of the time and is really only comfortable when the house is around 30 Celsius or 90 Fahrenheit.  I, of course, can’t bare the temperature being that high.

 

 

 

About a month ago she informed me that she hadn’t urinated all day and was in a great deal of pain.  Of course, I had to drive her the 40 miles to the emergency.  My husband could not come because he still couldn’t walk at this stage.  An ultrasound showed that she had two kidney stones that were small enough to pass.  They prescribed antibiotics and dilaudin for the pain.  She seemed to pass these stones a few days later.

 

 

 

But, that did not account for the strange blood work and pain in her lower back.  To date she has seen an urologist, an internist, and a nephrologist.  We are now awaiting the results of the many tests that have been preformed on her urine, blood, and body. 

 

 

 

I am so happy that Canada has Medicare.  We have not had to pay for any of the doctors or procedures.  Both my daughter and my husband were able to be admitted to the ER and see their respective specialists without delay.  Within 3 weeks of being in the emergency department  my daughter saw all the specialists and had all the tests preformed, without waiting and without charges.

 

 

 

Needless to say, this has been a very hectic time for our family.  My brain is only just now starting to be able to guide me in my research and interpretations of the research that I must do for this blog.  I always transform my research into layman’s terms so you, my readers, can understand it.

 

 

 

 

 

Bonnie

 

 

 

Emergency, Medicare, pain, blood clot, white blood count,

 

 

 

 

 

 

 

 

 

 

 

 

Multiple Sclerosis Impact Scale (MSIS-29)

 

 

• The following questions ask for your views about the impact of MS on your day-to-day life during the past two weeks

 

• For each statement, please circle the one number that best describes your situation

 

• Please answer all questions

 

 

The following may not appear on your screen completely.  I am unable to change the font size in WordPress.  Therefore I will tell what each of the columns are:

 

1. Not at all       
2. A little  
3. Moderately               
4. Quite a bit     
5. Extremely

 

In the past two weeks, how much has your MS limited your ability to… Not at all A little Moderately Quite a bit Extremely   1. Do physically demanding tasks?   1 2 3 4 5 2. Grip things tightly (e.g. turning on taps)? 1 2 3 4 5 3. Carry things?   1 2 3 4 5

 

In the past two weeks, how much have you been bothered by… Not at all A little Moderately Quite a bit Extremely   4. Problems with your balance?   1 2 3 4 5 5. Difficulties moving about indoors? 1 2 3 4 5 6. Being clumsy?   1 2 3 4 5 7. Stiffness?   1 2 3 4 5 8. Heavy arms and/or legs?   1 2 3 4 5 9. Tremor of your arms or legs?   1 2 3 4 5 10. Spasms in your limbs?   1 2 3 4 5 11. Your body not doing what you want it to do? 1 2 3 4 5 12. Having to depend on others to do things for you? 1 2 3 4 5   Please check that you have answered all the questions before going on to the next page

 

 

 

 

In the past two weeks, how much have you been bothered by… Not at all A little Moderately Quite a bit Extremely   13. Limitations in your social and leisure activities at home? 1 2 3 4 5 14. Being stuck at home more than you would like to be? 1 2 3 4 5 15. Difficulties using your hands in everyday tasks? 1 2 3 4 5 16. Having to cut down the amount of time you spent on work or other daily activities? 1 2 3 4 5 17. Problems using transport (e.g. car, bus, train, taxi, etc.)? 1 2 3 4 5 18. Taking longer to do things?   1 2 3 4 5 19. Difficulty doing things spontaneously (e.g. going out on the spur of the moment)? 1 2 3 4 5 20. Needing to go to the toilet urgently? 1 2 3 4 5 21. Feeling unwell?   1 2 3 4 5 22. Problems sleeping?   1 2 3 4 5 23. Feeling mentally fatigued?   1 2 3 4 5 24. Worries related to your MS?   1 2 3 4 5 25. Feeling anxious or tense?   1 2 3 4 5 26. Feeling irritable, impatient, or short tempered? 1 2 3 4 5 27. Problems concentrating?   1 2 3 4 5 28 Lack of confidence?   1 2 3 4 5 29. Feeling depressed?   1 2 3 4 5   Please check that you have circled ONE number for EACH question