Clinical Trials /

A Phase II Study of MS-275, in Combination With GM-CSF Treating Relapsed and Refractory Myeloid Malignancies

NCT00466115

Description:

This research is being done to see if the combination of sargramostim and MS-275 will help to improve the bone marrow function of people with myelodysplastic syndrome (MDS) or acute myeloid leukemia(AML). It will also determine the side effects of this combination.

Related Conditions:
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndromes
Recruiting Status:

Unknown status

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Phase II Study of MS-275, in Combination With GM-CSF Treating Relapsed and Refractory Myeloid Malignancies
  • Official Title: A Phase II Study of an Oral Histone Deacetylase Inhibitor, MS-275 (NSC 706995), in Combination With Sargramostim (GM-CSF, Berlex, Inc.) Treating Relapsed and Refractory Myeloid Malignancies

Clinical Trial IDs

  • ORG STUDY ID: NCI Protocol : #7605
  • NCT ID: NCT00466115

Conditions

  • Myelodysplastic Syndrome
  • Acute Myeloid Leukemia

Interventions

DrugSynonymsArms
MS-275
GM-CSF

Purpose

This research is being done to see if the combination of sargramostim and MS-275 will help to improve the bone marrow function of people with myelodysplastic syndrome (MDS) or acute myeloid leukemia(AML). It will also determine the side effects of this combination.

Detailed Description

      MDS is an abnormality of the bone marrow and blood cells that may develop into cancer.

      AML is a cancer of the bone marrow and blood cells. Both result in problems making normal
      blood cells. The cells in the bone marrow do not undergo the normal expected patterns of
      growth or maturation that is called “differentiation.” Because of this, they do not work very
      well. People with these problems often need blood transfusions and are at high risk for
      infections and bleeding.

      Treatment options for MDS and AML are often limited due to their side effects. We hope to
      develop combinations of drugs that will help the bone marrow function better without many of
      the side effects of traditional chemotherapy treatments.
    

Trial Arms

NameTypeDescriptionInterventions

Eligibility Criteria

        Inclusion Criteria:

        In general, patients with MDS and relapsed or refractory AML, who are not eligible for a
        potentially curative myeloablative allogeneic stem cell transplant or who are considered
        poor candidates for such a procedure due to age, medical co-morbidities, or lack of a
        suitable donor, will be considered for participation in the proposed trial.

        Disease Specific Inclusion Criteria:

          -  MDS

          -  Relapsed AML

          -  Untreated AML

        Additional Criteria:

          1. Age > 18.

          2. JHOC confirmed and documented diagnosis of either AML or MDS within 12 weeks of trial
             enrollment. Patients with MDS are restricted to those with IPSS of INT-2 or high risk.

          3. Patients must have relatively stable bone marrow function for more than seven days
             prior to enrollment on the study. WBC count doubling within seven days of enrollment
             or WBC greater than 10 x 103/dL would indicate unstable bone marrow function.

          4. ECOG performance status of 0, 1, 2.

          5. Patient or caregiver must be willing to perform subcutaneous injection.

          6. Patients must have the following end organ function:

               -  Serum creatinine < 2.0 mg/dL

               -  Total serum bilirubin < 1.6 mg/dL, unless secondary to hemolysis.

               -  SGOT/SGPT each < 3 times the upper limit of normal unless disease related

               -  Hemoglobin should be at least 8 gm/dL at the time of protocol entry. Patients may
                  receive transfusions to achieve this level.

          7. Patients must not have received treatment for their myeloid disorder within 2 weeks of
             beginning the trial. Treatments include the use of chemotherapy, hematopoietic growth
             factors, and biologic therapy such as monoclonal antibodies. The exception is the use
             of hydroxyurea for patients with WBC > 30 x 103/μL. This duration of time appears
             adequate for wash out due to the relatively short-acting nature of most anti-leukemia
             agents.

          8. Patients must have recovered from all toxicities (to grade 0 or 1) associated with
             previous treatment.

          9. Patients must not have any clinical symptoms of active CNS disease. If CNS disease is
             suspected, patient must have LP with negative cytology.

         10. All women of potential child bearing must have negative urine or serum B-HCG prior to
             enrollment.

         11. All women of potential child bearing must agree to use adequate birth control
             throughout the trial period. All men must agree to use barrier contraceptive
             throughout the trial period.

         12. Patients must be able to provide informed consent and to return to clinic for adequate
             follow up as required by the protocol.

        Exclusion Criteria:

          1. Diagnosis of RA with 5q- syndrome

          2. Peripheral leukemia with blast count > 30 x 103/dL, uncontrolled with hydroxyurea.

          3. Age < 18

          4. ECOG performance status > 3

          5. Patients with untreated or progressive infections

          6. Patients with active CNS disease

          7. Patients with a previous history of intolerance to GM-CSF

          8. Pregnant or lactating women
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:All patient initiated on combination therapy will be evaluable for toxicity. Efficacy will be evaluated following two cycles of therapy.
Time Frame:
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Unknown status
Lead Sponsor:Johns Hopkins University

Trial Keywords

  • MDS
  • AML

Last Updated

April 25, 2007