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.
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
Drug | Synonyms | Arms |
---|
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
Name | Type | Description | Interventions |
---|
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
Last Updated
April 25, 2007