Clinical trial NCT01535456: FLT-PET Imaging for MDS
Official title: A Pilot Study for Using 18F-FLT PET Imaging To Assess Response In Patients With Myelodysplastic Syndrome (MDS) Being Treated With 5-azacitidine
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: AML
MDS
Keywords: MDS
AML
5 azacitidine
FLT PET
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2012-02-17
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: feasibility of using FLT-PET to assess chemotherapy response in AML/MDS
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Ryan J Mattison, MD
role: PRINCIPAL_INVESTIGATOR
References: