FLT-PET in Predicting Response to Chemotherapy in Patients With Advanced Malignancies

Last updated: June 23, 2023
Sponsor: M.D. Anderson Cancer Center
Overall Status: Completed

Phase

1

Condition

Neoplasms

Treatment

Positron Emission Tomography

Laboratory Biomarker Analysis

Fluorothymidine F-18

Clinical Study ID

NCT00880074
2008-0106
NCI-2012-01625
NCI-2010-01046
2008-0106
  • Ages > 18
  • All Genders

Study Summary

This clinical trial studies fluorine F-18 fluorothymidine (FLT)-positron emission tomography (PET) in predicting response to chemotherapy in patients with advanced malignancies. FLT solution can help locate cancer cells inside the body. Diagnostic procedures, such as FLT-PET, may help find tumors and measure a patient's response to treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients actively enrolled and being treated on protocol 2007-0668: CombinationTherapy with Bevacizumab and Temsirolimus in Patients with Advanced Malignancy at M.D.Anderson Cancer Center; these patients must have met the inclusion and exclusioncriteria for that protocol
  • Women of child-bearing potential (as defined as women who are not post-menopausal for 12 months or who have had no previous surgical sterilization) and men must agree touse adequate contraception (hormonal or barrier method of birth control; abstinence)prior to study entry, for the duration of study participation, and for 90 days afterthe last dose
  • Ability to understand and the willingness to sign a written informed consent document
  • Patient actively enrolled and being treated on protocol 2012-0061 "A Phase I Trial ofBevacizumab, Temsirolimus Alone and in Combination with Valproic Acid or Cetuximab inPatients with Advanced Malignancy" at M.D. Anderson Cancer Center

Exclusion

Exclusion Criteria:

  • Pregnant or breast-feeding women
  • History of hypersensitivity to 3'-deoxy-3'-18F-fluorothymidine (18F-FLT) or anycomponent of the formulation

Study Design

Total Participants: 10
Treatment Group(s): 3
Primary Treatment: Positron Emission Tomography
Phase: 1
Study Start date:
April 09, 2009
Estimated Completion Date:
February 04, 2022

Study Description

PRIMARY OBJECTIVES:

I. To determine if concurrent treatment with temsirolimus and bevacizumab demonstrates a dose-dependent decrease in FLT-PET standardized uptake value which correlates with clinical response.

SECONDARY OBJECTIVES:

I. To determine the relationship between FLT-PET and markers of angiogenesis and drug activity in tumor biopsy, along with surrogate peripheral blood markers of target inhibition and drug activity.

OUTLINE:

Patients undergo fluorine F-18 fluorothymidine PET at baseline, at day 6-8 of course 1, day 20 of course 2, and prior to day 1 of course 3.

Connect with a study center

  • M D Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

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