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


Phase 2
18 Years
72 Years
Not Enrolling
Both
Myelodysplastic Syndromes

Thank you

Trial Information

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


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.

Inclusion Criteria


- INCLUSION CRITERIA:

1. 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.

2. Off all other treatments for MDS, except red blood cell transfusion support for
at least 4 weeks.

3. Anemia as defined by hemoglobin less than 11g/dL.

4. Absolute reticulocyte count less than 60,000/microliter based on two baseline
lab tests.

5. Absolute neutrophil count greater than 200/microliter.

6. Platelet count greater than 10,000/microliter.

7. Ages 18 to 72.

8. ECOG performance status less than or equal to 2.

9. Ability to understand the investigational nature of the protocol and provide
informed consent.

EXCLUSION CRITERIA:

1. MDS patients in high IPSS risk group.

2. Patients with secondary MDS.

3. Previous history of dystonic reaction and/or anaphylactic reaction to metoclopramide.

4. 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

5. 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

6. Concomitant drug therapy with high risks of extrapyramidal side effects (namely
antipsychotic drugs including haloperidol, trifluoperazine, fluphenazine,
thiothixene, perphenazine and pimozide).

7. Metoclopramide therapy 4 months prior to study enrollment.

8. Hyperprolactinemia prior to study implementation (prolactin greater than 200 ng/ml).

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

050201

NCT ID:

NCT00120653

Start Date:

July 2005

Completion Date:

June 2008

Related Keywords:

  • Myelodysplastic Syndromes
  • Reglan
  • Prolactin
  • MDS
  • Metoclopramide
  • Myelodysplastic Syndrome
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location
National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda, Maryland  20892
University of Washington Seattle, Washington  98195