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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Johns Hopkins University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00466115
First received: April 25, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  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.


Condition Intervention Phase
Myelodysplastic Syndrome
Acute Myeloid Leukemia
Drug: MS-275
Drug: GM-CSF
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • All patient initiated on combination therapy will be evaluable for toxicity. Efficacy will be evaluated following two cycles of therapy.

Estimated Enrollment: 18
Study Start Date: April 2007
Estimated Study Completion Date: April 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00466115

Contacts
Contact: B.Douglas Smith, MD (410) 287-2935 smithdo@jhmi.edu
Contact: Katy Rogers, RN 410-614-1766 krogers7@jhmi.edu

Locations
United States, Maryland
Johns Hopkins University - Sidney Kimmel Comprehensive Cancer Center Not yet recruiting
Baltimore, Maryland, United States, 21231
Contact: Katy Rogers, RN    410-955-8804    jhcccro@jhmi.edu   
Contact: Katy Rogers, RN    410-614-1766    krogers@jhmi.edu   
Principal Investigator: B.Douglas Smith, MD         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: B.Douglas Smith, MD Johns Hopkins University
Study Chair: Katy Rogers, RN Johns Hopkins University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00466115     History of Changes
Other Study ID Numbers: NCI Protocol : #7605
Study First Received: April 25, 2007
Last Updated: April 25, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
MDS
AML

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Preleukemia
Leukemia
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014