Clinical trial NCT01143779: FLT-PET as an Imaging Biomarker With Temsirolimus, Topotecan, and Bortezomib
Official title: FLT-PET as an Imaging Biomarker in Patients Receiving the Combination of Cell Cycle Inhibitors Temsirolimus, Topotecan, and Bortezomib
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Cancer
Keywords: Advanced Malignancy
FLT-PET Scan
[F-18]-fluoro-L-thymidine
FLT
Positron emission tomography
PET
Imaging Biomarker
Temsirolimus
Topotecan
Bortezomib
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2010-06-14
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. 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.
3. Ability to understand and the willingness to sign a written informed consent document.
4. Patients must be at least 18 years of age

Exclusion Criteria:

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

Primary outcomes:
measure: Patient Standardized Uptake Value (SUV)
timeFrame: Cycle 1, Day 21
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Sarina Piha-Paul, MD
role: PRINCIPAL_INVESTIGATOR
References: