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

June 23, 2023 updated by: M.D. Anderson Cancer Center

Early Prediction of Clinical Response to Chemotherapy With FLT-PET

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients actively enrolled and being treated on protocol 2007-0668: Combination Therapy with Bevacizumab and Temsirolimus in Patients with Advanced Malignancy at M.D. Anderson Cancer Center; these patients must have met the inclusion and exclusion criteria 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 to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days after the 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 of Bevacizumab, Temsirolimus Alone and in Combination with Valproic Acid or Cetuximab in Patients with Advanced Malignancy" at M.D. Anderson Cancer Center

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnostic (fluorine F-18 fluorothymidine PET)
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.
Other: Laboratory Biomarker Analysis
Optional correlative studies
Drug: Fluorothymidine F-18
Undergo fluorine F-18 fluorothymidine PET
Other Names:
  • 18F-FLT
  • 3'-deoxy-3'-[18F]fluorothymidine
  • 3'-Deoxy-3'-(18F) Fluorothymidine
  • Fluorothymidine F 18
  • ALOVUDINE F-18
Procedure: Positron Emission Tomography
Undergo fluorine F-18 fluorothymidine PET
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging
  • PT
  • Positron emission tomography (procedure)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response to Chemotherapy Shown in FLT-PET Scans
Time Frame: through study completion; an average of 1 year.
through study completion; an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Sarina A Piha-Paul, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2009

Primary Completion (Actual)

February 4, 2022

Study Completion (Actual)

February 4, 2022

Study Registration Dates

First Submitted

April 9, 2009

First Submitted That Met QC Criteria

April 10, 2009

First Posted (Estimated)

April 13, 2009

Study Record Updates

Last Update Posted (Actual)

June 26, 2023

Last Update Submitted That Met QC Criteria

June 23, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-0106 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2012-01625 (Other Identifier: NCI-CTRP Clinical Trials Registry)
  • NCI-2010-01046

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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