Advanced CancerPhase 1NCT01143779
FLT-PET as an Imaging Biomarker With Temsirolimus, Topotecan, and Bortezomib
A Phase 1 study testing FLT-PET in people with Advanced Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if an imaging solution, [F-18]-fluoro-L-thymidine (FLT), when used with a positron emission tomography (PET) scan, can help doctors to better see changes in the growth of tumors in the body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- FLT-PET
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to 27 Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients enrolled on Protocol 2008-0425: "A Phase I Study of Temsirolimus, Topotecan, and Bortezomib in Patients with Advanced Malignancy" or Protocol 2012-0061: "A Phase I Trial of Bevacizumab, Temsirolimus Alone and in Combination with Valproic Acid or Cetuximab in Patients with Advanced Malignancy" are eligible. 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.
- Patients must be at least 18 years of age
Who cannot join
- Pregnant or breast-feeding women.
- History of hypersensitivity to 3'-deoxy-3'-18F-fluorothymidine (18F- FLT) or any component of the formulation.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: FLT-PET as an Imaging Biomarker in Patients Receiving the Combination of Cell Cycle Inhibitors Temsirolimus, Topotecan, and Bortezomib
The goal of this clinical research study is to learn if an imaging solution, [F-18]-fluoro-L-thymidine (FLT), when used with a positron emission tomography (PET) scan, can help doctors to better see changes in the growth of tumors in the body. Researchers want to learn if FLT-PET scans can show an early response to chemotherapy.
Read the detailed description
FLT-PET Scan:
An FLT-PET scan uses the FLT solution, which contains a small amount of radioactive material, to help locate cancer cells inside the body. This scan may help doctors find solid tumors as well as learn if these tumors are growing and how fast they are growing. This information could be used to help predict if the cancer will respond to treatment.
Study Visits:
Within 2 weeks before Day 1 of Cycle 1 and between Days 19 and 21 of Cycle 1, you will have a FLT-PET scan.
For at least 4 hours before the FLT-PET scan, you must not eat or drink anything. You will receive the FLT solution by vein. The FLT solution is a mildly radioactive material. The radioactive nature of the solution allows the scanner to "see" it in certain places in your body. After the injection, you will need to rest quietly until it is time for the scan. The amount of rest time may vary, but be prepared to wait for about 60 minutes. During the scan, you will lie flat on your back on a table. After the solution is injected into a vein, the PET scanner takes pictures of the radioactive solution as it moves through the body and collects at various sites in the body. By watching how the solution travels through the body and studying where the solution collects, researchers can learn the status of disease in the body. The scan itself may last about 40-60 minutes.
Your vital signs (blood pressure, heart rate, temperature, and breathing rate) will be measured before each injection of the FLT solution, 30 minutes after each injection, and before each PET scan. You will be allowed to leave 30 minutes after your scan, if your vital signs are acceptable.
Length of Study:
You will be off this study after the second FLT-PET scan. You will be taken off study early if you have intolerable side effects or the study doctor thinks it is in your best interest.
This is an investigational study. The FLT solution is not FDA approved or commercially available. At this time, FLT solution is only being used in research.
Up to 5 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Advanced Cancer
- Being tested
- FLT-PET
- Keywords
- Advanced Malignancy, FLT-PET Scan, [F-18]-fluoro-L-thymidine, FLT, Positron emission tomography, PET, Imaging Biomarker, Temsirolimus, Topotecan, Bortezomib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLT-PETDrug
Also called [F-18]-fluoro-L-thymidine, positron emission tomography
FLT-PET scan uses the FLT solution (dosage of FLT in range between 1 and 10 mCi) with imaging performed 60-90 minutes after FLT intravenous injection.
| Study group | Role | What they receive |
|---|---|---|
| FLT-PET | Experimental | FLT-PET scan uses the FLT solution (dosage of FLT in range between 1 and 10 mCi) with imaging performed 60-90 minutes after FLT intravenous injection. Receives: Drug: FLT-PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Standardized Uptake Value (SUV)
SUV measured on continuous scale at two specified time points (baseline and post-treatment phase, cycle 1, day 19-21).
Measured: Cycle 1, Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2010 (estimated)
- Study startJun 2010
- Primary completion27 Dec 2021
- Study completion27 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarina Piha-Paul, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01143779
- Sponsor's protocol ID
- 2009-0658
- Status last verified
- Jan 2022
- First submitted
- 11 Jun 2010
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FLT-PET as an Imaging Biomarker in Patients Receiving the Combination of Cell Cycle Inhibitors Temsirolimus, Topotecan, and Bortezomib
- ClinicalTrials.gov ID
- NCT01143779
- Acronym / sponsor ID
- 2009-0658
- Conditions
- Advanced Cancer
- Keywords
- Advanced Malignancy, FLT-PET Scan, [F-18]-fluoro-L-thymidine, FLT, Positron emission tomography, PET, Imaging Biomarker, Temsirolimus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jun 2010 (actual)
- Primary completion
- 27 Dec 2021 (actual)
- Study completion
- 27 Dec 2021 (actual)
- First posted
- 14 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if an imaging solution, [F-18]-fluoro-L-thymidine (FLT), when used with a positron emission tomography (PET) scan, can help doctors to better see changes in the growth of tumors in the body. Researchers want to learn if FLT-PET scans can show an early response to chemotherapy.
Detailed description
FLT-PET Scan:
An FLT-PET scan uses the FLT solution, which contains a small amount of radioactive material, to help locate cancer cells inside the body. This scan may help doctors find solid tumors as well as learn if these tumors are growing and how fast they are growing. This information could be used to help predict if the cancer will respond to treatment.
Study Visits:
Within 2 weeks before Day 1 of Cycle 1 and between Days 19 and 21 of Cycle 1, you will have a FLT-PET scan.
For at least 4 hours before the FLT-PET scan, you must not eat or drink anything. You will receive the FLT solution by vein. The FLT solution is a mildly radioactive material. The radioactive nature of the solution allows the scanner to "see" it in certain places in your body. After the injection, you will need to rest quietly until it is time for the scan. The amount of rest time may vary, but be prepared to wait for about 60 minutes. During the scan, you will lie flat on your back on a table. After the solution is injected into a vein, the PET scanner takes pictures of the radioactive solution as it moves through the body and collects at various sites in the body. By watching how the solution travels through the body and studying where the solution collects, researchers can learn the status of disease in the body. The scan itself may last about 40-60 minutes.
Your vital signs (blood pressure, heart rate, temperature, and breathing rate) will be measured before each injection of the FLT solution, 30 minutes after each injection, and before each PET scan. You will be allowed to leave 30 minutes after your scan, if your vital signs are acceptable.
Length of Study:
You will be off this study after the second FLT-PET scan. You will be taken off study early if you have intolerable side effects or the study doctor thinks it is in your best interest.
This is an investigational study. The FLT solution is not FDA approved or commercially available. At this time, FLT solution is only being used in research.
Up to 5 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FLT-PET | Experimental | Drug: FLT-PETFLT-PET scan uses the FLT solution (dosage of FLT in range between 1 and 10 mCi) with imaging performed 60-90 minutes after FLT intravenous injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients enrolled on Protocol 2008-0425: "A Phase I Study of Temsirolimus, Topotecan, and Bortezomib in Patients with Advanced Malignancy" or Protocol 2012-0061: "A Phase I Trial of Bevacizumab, Temsirolimus Alone and in Combination with Valproic Acid or Cetuximab in Patients with Advanced Malignancy" are eligible. 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.
- Patients must be at least 18 years of age
Key exclusion criteria (2 listed)
- Pregnant or breast-feeding women.
- History of hypersensitivity to 3'-deoxy-3'-18F-fluorothymidine (18F- FLT) or any component of the formulation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FLT-PETAlso: [F-18]-fluoro-L-thymidine, positron emission tomographyFLT-PET scan uses the FLT solution (dosage of FLT in range between 1 and 10 mCi) with imaging performed 60-90 minutes after FLT intravenous injection. | Drug | FLT-PET |
Primary outcome
Patient Standardized Uptake Value (SUV)
Time frame: Cycle 1, Day 21
SUV measured on continuous scale at two specified time points (baseline and post-treatment phase, cycle 1, day 19-21).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarina Piha-Paul, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FLT-PET in people with Advanced Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Standardized Uptake Value (SUV) (time frame: Cycle 1, Day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.