FLT-PET Imaging for MDS

NCT01535456 | Terminated DMC

• 5 other identifiers: HO10417A534260SMPH\MEDICINE\HEM-ONCNCI-2012-003622011-0285
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

AML; MDS

Keywords

MDS; AML; 5 azacitidine; FLT PET

Outcome Measures

Primary Outcomes (1)

• feasibility of using FLT-PET to assess chemotherapy response in AML/MDS

  This pilot study is intended to investigate the feasibility of FLT-PET for early assessment of treatment response in myelodysplastic syndrome and the use of a PET isotope, (18)F-FLT, in the imaging of bone marrow in subjects with MDS. The objectives will help gather initial information for a future, larger, more definitive study.

  3 years

Study Arms (1)

F-FLT PET scan, 5-azacitidine treatment

EXPERIMENTAL

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.

Procedure: FLT-PET scans

Interventions

FLT-PET scans PROCEDURE

FLT-PET scans prior to treatment, after Cycle 1, after Cycle 4

F-FLT PET scan, 5-azacitidine treatment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Study Officials

• Ryan J Mattison, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2012
• First Posted: February 17, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: March 1, 2014
• Last Updated: December 13, 2019

Record last verified: 2015-04

Locations

US (1)