FLT-PET Imaging for MDS
| Status: | Completed |
|---|---|
| Conditions: | Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/13/2015 |
| Start Date: | July 2012 |
| End Date: | January 2016 |
| Contact: | Ryan J Mattison, MD |
| Email: | rjmattison@medicine.wisc.edu |
| Phone: | 608-262-5697 |
A Pilot Study for Using 18F-FLT PET Imaging To Assess Response In Patients With Myelodysplastic Syndrome (MDS) Being Treated With 5-azacitidine
The main purpose of this study is to see if this tracer can be used to determine how well
chemotherapy is working in patients with certain types of leukemia.
chemotherapy is working in patients with certain types of leukemia.
Primary objectives
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
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
Inclusion Criteria:
- All subjects with previously untreated, Intermediate-2 or High risk myelodysplastic
syndrome are eligible. These patients have an international prognostic scoring
system (IPSS) score of 1.5 to 3.5 based on bone marrow blast percentage, karyotype,
and the number of cytopenias 26.
- 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 who are pregnant or breast feeding
- 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
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