Official Title: “Metoclopramide to Treat Anemia in Patients With Myelodysplastic Syndrome (MDS)”

RATIONALE: Metoclopramide may cause the body to make more red blood cells. It may treat anemia due to myelodysplastic syndromes.

PURPOSE: This phase II trial is studying how well metoclopramide works in treating patients with anemia due to myelodysplastic syndromes.

Study Type: Interventional

Study Design: Treatment, Open Label

Study Primary Completion Date: December 2008

OBJECTIVES: - Determine the effectiveness of metoclopramide, as measured by stimulation of erythropoiesis, in patients with anemia due to myelodysplastic syndromes. - Determine any negative effects of transfusional iron-overload, as measured by serum ferritin, on the stimulation of prolactin release in patients treated with this drug. - Correlate clinical response with elevated prolactin levels in patients treated with this drug.

OUTLINE: Patients receive oral metoclopramide three times daily for up to 20 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at approximately 1 month.

PROJECTED ACCRUAL: A total of 44-60 patients will be accrued for this study.

Intervention(s) in this Clinical Trial

• Drug: metoclopramide hydrochloride

Primary Measures

• Erythroid response (major and minor response) at 5 months
  • Safety Issue?: No

Secondary Measures

• Prolactin response at study entry
  • Safety Issue?: No
• Transfusion requirement response
  • Safety Issue?: No

DISEASE CHARACTERISTICS:

• Diagnosis of myelodysplastic syndromes (MDS), meeting 1 of the following criteria:
• International Prognostic Scoring System (IPSS) risk group low or intermediate-1
• IPSS risk group intermediate-2 allowed provided patient is > 60 years of age and is not eligible for high intensity therapies (i.e., intensive combination chemotherapy or hematopoietic stem cell transplantation)
• Anemia, defined as hemoglobin < 11 g/dL
• No secondary MDS

PATIENT CHARACTERISTICS:

• Age
• 18 to 72
• Performance status
• ECOG 0-2
• Life expectancy
• Not specified
• Hematopoietic
• See Disease Characteristics
• Absolute reticulocyte count < 31,700/mm^3
• Absolute neutrophil count > 200/mm^3
• Platelet count > 10,000/mm^3
• Hepatic
• Not specified
• Renal
• Creatinine clearance > 50 mL/min
• Cardiovascular
• No hypertension due to pheochromocytoma
• Other
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No history of dystonic reaction and/or anaphylactic reaction to metoclopramide
• No history of gastrointestinal obstruction/perforation
• No history of pheochromocytoma
• No history of seizure disorders
• No history of Parkinson's disease
• No history of breast cancer
• No history of clinically active depression

PRIOR CONCURRENT THERAPY:

• Biologic therapy
• Not specified
• Chemotherapy
• Not specified
• Endocrine therapy
• Not specified
• Radiotherapy
• Not specified
• Surgery
• Not specified
• Other
• At least 4 months since prior metoclopramide
• At least 4 weeks since prior treatment for MDS except red blood cell transfusion
• No concurrent drug with high risk of extrapyramidal side effects (e.g., antipsychotic drugs, such as haloperidol, trifluoperazine, fluphenazine, thiothixiene, perphenazine, or pimozide)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 72 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Overall Clinical Trial Officials and Contacts

Andre Larochelle, MD, PhD Principal Investigator National Heart, Lung, and Blood Institute (NHLBI)  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00238134

Study ID Number: CDR0000443669

ClinicalTrials.gov Identifier: NCT00238134

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database