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
-
-
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
14 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.
|
Optional correlative studies
Undergo fluorine F-18 fluorothymidine PET
Other Names:
Undergo fluorine F-18 fluorothymidine PET
Other Names:
|
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
Collaborators
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.