Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00120653
Status:
WITHDRAWN
Last Update Posted:
2017-07-02
First Post:
2006-06-19
Brief Title:
Metoclopramide to Treat Anemia in Patients With Myelodysplastic Syndrome MDS
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Metoclopramide to Treat Anemia in Patients With Myelodysplastic Syndrome MDS
Status:
WITHDRAWN
Status Verified Date:
2008-06-17
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will determine whether the medication metoclopramide can improve red blood counts in people who have myelodysplastic syndrome MDS MDS is thought to affect blood stem cells which can result in low levels of red blood cells-that is anemia-as well as low white blood cell and platelet counts Patients with MDS are at risk for infection spontaneous bleeding and possible progression to leukemia a cancer of bone marrow Although bone marrow can produce some blood cells this production can be decreased in patients with MDS The definitive way to treat MDS is stem cell transplantation but serious complications and a high risk of death make it unsuitable for patients older than age 60 or those who do not have a matched sibling donor However scientists have noted improvement in anemia by using metoclopramide an inexpensive commonly used medication that does not have many negative side effects This study will evaluate the safety and effectiveness of that medicine for patients with MDS
Patients ages 18 to 72 whose MDS would require low-intensity treatment-for example with growth factor and transfusions-and who are not pregnant or breastfeeding may be eligible for this study There will be about 60 participants
Screening tests include a complete physical examination and medical history during which patients will provide a list of current medications or supplements they are taking There will be a collection of about 4 tablespoons of blood for analysis of blood counts as well as liver and kidney function Patients may also undergo a magnetic resonance imaging MRI scan of their brain but the procedure is optional During the MRI they will lie on a table that will slide into the enclosed tunnel of the scanner The MRI takes about 20 to 30 minutes and patients will be asked to lie as still as possible There will also be a bone marrow biopsy if patients have not had one done within 4 weeks of the start of this study Eligible patients will take a 10 mg dose of metoclopramide by mouth three times a day for 20 weeks They will be given a 4-week supply which will be renewed monthly at each treatment visit It is essential that patients be seen at NIH during the first third and fifth months of the study Visits made in the meantime at the second and fourth months may be done at the office of their doctors who have referred them for the study or at NIH During the treatment visits patients will be asked to update their medical history health conditions and use of medications or herbal supplements There will also be a collection of about 1 tablespoon of blood for laboratory tests Patients will be asked to make a similar follow-up visit 1 month after they stop taking metoclopramide so that the response to treatment can be evaluated
The use of metoclopramide may cause some people to feel dizzy lightheaded tired or less alert than they are normally For the first 24 to 48 hours patients should be cautious when driving using machinery or performing hazardous activities This medicine will add to the effects of alcohol and other central nervous system depressants-such as medicines for allergies and colds tranquilizers and prescription pain relievers Patients need to check with the research team before taking any of those types of medicines as well as herbal supplements while using metoclopramide
This study may or may not have a direct benefit for participants For some the drug may improve red blood cell counts and decrease the need for red cell transfusions Knowledge gained in the study may help people in the future
Patients ages 18 to 72 whose MDS would require low-intensity treatment-for example with growth factor and transfusions-and who are not pregnant or breastfeeding may be eligible for this study There will be about 60 participants
Screening tests include a complete physical examination and medical history during which patients will provide a list of current medications or supplements they are taking There will be a collection of about 4 tablespoons of blood for analysis of blood counts as well as liver and kidney function Patients may also undergo a magnetic resonance imaging MRI scan of their brain but the procedure is optional During the MRI they will lie on a table that will slide into the enclosed tunnel of the scanner The MRI takes about 20 to 30 minutes and patients will be asked to lie as still as possible There will also be a bone marrow biopsy if patients have not had one done within 4 weeks of the start of this study Eligible patients will take a 10 mg dose of metoclopramide by mouth three times a day for 20 weeks They will be given a 4-week supply which will be renewed monthly at each treatment visit It is essential that patients be seen at NIH during the first third and fifth months of the study Visits made in the meantime at the second and fourth months may be done at the office of their doctors who have referred them for the study or at NIH During the treatment visits patients will be asked to update their medical history health conditions and use of medications or herbal supplements There will also be a collection of about 1 tablespoon of blood for laboratory tests Patients will be asked to make a similar follow-up visit 1 month after they stop taking metoclopramide so that the response to treatment can be evaluated
The use of metoclopramide may cause some people to feel dizzy lightheaded tired or less alert than they are normally For the first 24 to 48 hours patients should be cautious when driving using machinery or performing hazardous activities This medicine will add to the effects of alcohol and other central nervous system depressants-such as medicines for allergies and colds tranquilizers and prescription pain relievers Patients need to check with the research team before taking any of those types of medicines as well as herbal supplements while using metoclopramide
This study may or may not have a direct benefit for participants For some the drug may improve red blood cell counts and decrease the need for red cell transfusions Knowledge gained in the study may help people in the future
Detailed Description:
Patients with myelodysplastic syndrome MDS present with low red blood cells white blood cells and platelets alone or in combination The only definitive treatment is stem cell transplantation Unfortunately treatment-related mortality precludes the application of this procedure for most patients older than 60 years and those lacking a suitable matched sibling donor A proportion of patients have been shown to respond to a wide variety of immunosuppressive agents including cyclosporine CSA and antithymocyte globulin ATG However nonresponse and relapse continue to be problematic Therefore most patients with MDS receive supportive treatment with transfusions and growth factors such as erythropoietin EPO and G-CSF to improve blood counts However growth factors are not always effective in improving cytopenias and iron overload is an inevitable long-term complication of red blood cell transfusions
Recently Abkowitz et al described clinically significant improvement in anemia in 3 of 9 patients with Diamond-Blackfan anemia DBA using metoclopramide an inexpensive commonly used medication with rare side effects We hypothesize that therapy with metoclopramide might also benefit patients with other causes of refractory anemia such as individuals with anemia due to MDS We therefore propose this Phase II clinical trial to evaluate metoclopramide in the treatment of anemia in patients with MDS
Recently Abkowitz et al described clinically significant improvement in anemia in 3 of 9 patients with Diamond-Blackfan anemia DBA using metoclopramide an inexpensive commonly used medication with rare side effects We hypothesize that therapy with metoclopramide might also benefit patients with other causes of refractory anemia such as individuals with anemia due to MDS We therefore propose this Phase II clinical trial to evaluate metoclopramide in the treatment of anemia in patients with MDS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-H-0201 | None | None | None |