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Status:

WITHDRAWN

Metoclopramide to Treat Anemia in Patients With Myelodysplastic Syndrome (MDS)

Lead Sponsor:

National Heart, Lung, and Blood Institute (NHLBI)

Conditions:

Myelodysplastic Syndromes

Eligibility:

All Genders

18-72 years

Phase:

PHASE2

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 res...

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. Unf...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA:
  • MDS patients in IPSS risk group low or intermediate-1
  • OR
  • MDS patients in IPSS risk group intermediate-2 if greater than 60 years of age and not eligible for high intensity therapies, including intensive combination chemotherapy or hematopoietic cell transplant.
  • Off all other treatments for MDS, except red blood cell transfusion support for at least 4 weeks.
  • Anemia as defined by hemoglobin less than 11g/dL.
  • Absolute reticulocyte count less than 60,000/microliter based on two baseline lab tests.
  • Absolute neutrophil count greater than 200/microliter.
  • Platelet count greater than 10,000/microliter.
  • Ages 18 to 72.
  • ECOG performance status less than or equal to 2.
  • Ability to understand the investigational nature of the protocol and provide informed consent.
  • EXCLUSION CRITERIA:
  • MDS patients in high IPSS risk group.
  • Patients with secondary MDS.
  • Previous history of dystonic reaction and/or anaphylactic reaction to metoclopramide.
  • History of GI obstruction/perforation, pheochromocytoma, seizure disorders, creatinine clearance less than or equal to 50mL/min (estimated creatinine clearance = \[weight (Kg) x (140-age) x (0.85 if female)\]/\[72 x (stable creatinine)\], Parkinson's disease, breast cancer, clinically active depression, or hypertension due to pheochromocytoma
  • Current pregnancy (positive serum Beta-HCG if menstruating female), or unwilling to use a medically acceptable contraceptive or refrain from pregnancy if of childbearing potential
  • Concomitant drug therapy with high risks of extrapyramidal side effects (namely antipsychotic drugs including haloperidol, trifluoperazine, fluphenazine, thiothixene, perphenazine and pimozide).
  • Metoclopramide therapy 4 months prior to study enrollment.
  • Hyperprolactinemia prior to study implementation (prolactin greater than 200 ng/ml).

Exclusion

    Key Trial Info

    Start Date :

    July 14 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 17 2008

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00120653

    Start Date

    July 14 2005

    End Date

    June 17 2008

    Last Update

    July 2 2017

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, United States, 20892

    2

    University of Washington

    Seattle, Washington, United States, 98195