Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
1 participants
INTERVENTIONAL
2012-07-31
2014-03-31
Brief Summary
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Detailed Description
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1. To evaluate if FLT-PET uptake shows variation during the treatment course in subjects with MDS being treated with 5-azacitidine therapy
Secondary objectives
2. To assess FLT-PET uptake heterogeneity within given subjects being treated with 5-azacitidine therapy
3. To generate preliminary data regarding correlation between FLT-PET imaging parameters and clinical responses based on bone marrow aspirate/biopsy
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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F-FLT PET scan, 5-azacitidine treatment
F-FLT Pet scan followed by 5-azacitidine treatment followed by FLT-PET scan. Three additional cycles of 5-azacytidine and follow up FLT-PET scan.
FLT-PET scans
FLT-PET scans prior to treatment, after Cycle 1, after Cycle 4
Interventions
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FLT-PET scans
FLT-PET scans prior to treatment, after Cycle 1, after Cycle 4
Eligibility Criteria
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Inclusion Criteria
* Subjects will receive the standard FDA-approved dose and schedule of 5-azacitidine. This dose is 75mg/m2 SQ or IV daily for seven days with cycles repeated every 28 days
* The subject's treating physician must have an initial intent of treating with at least four cycles of therapy
* Subjects must have an ECOG performance status of 0, 1, or 2
* Subjects must not have been treated with chemotherapy or radiation for another malignancy within the preceding 6 months
* Subjects must be \> 18 years of age
* Subjects must have a serum creatinine \< 2.0 mg/dL and/or calculated GHF 50 ml/min/1.73m (MRDR formula) or greater
* Subjects must have a serum direct bilirubin \< 2.0 mg/dL unless related to Gilbert's syndrome of hemolysis. Alkaline phosphatase, SGOT (AST), and SGPT (ALT) must be less than 4 x upper limit of normal
* Women must not be pregnant nor breastfeeding
* Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception
Exclusion Criteria
* Subjects for whom a therapy other than 5-azacitidine is recommended as first line treatment.
* Allogeneic stem cell transplantation in patients with a suitable donor, lack of comorbidities, and good performance status
18 Years
100 Years
ALL
No
Sponsors
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University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Ryan J Mattison, MD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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University of Wisconsin
Madison, Wisconsin, United States
Countries
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Other Identifiers
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A534260
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH\MEDICINE\HEM-ONC
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2012-00362
Identifier Type: REGISTRY
Identifier Source: secondary_id
2011-0285
Identifier Type: OTHER
Identifier Source: secondary_id
HO10417
Identifier Type: -
Identifier Source: org_study_id