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FLT-PET as an Imaging Biomarker in Patients Receiving the Combination of Cell Cycle Inhibitors Temsirolimus, Topotecan, and Bortezomib


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced Cancer

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Trial Information

FLT-PET as an Imaging Biomarker in Patients Receiving the Combination of Cell Cycle Inhibitors Temsirolimus, Topotecan, and Bortezomib


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Patient Standardized Uptake Value (SUV)

Outcome Description:

SUV measured on continuous scale at two specified time points (baseline and post-treatment phase, cycle 1, day 19-21).

Outcome Time Frame:

Cycle 1, Day 21

Safety Issue:

No

Principal Investigator

Sarina Piha-Paul, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2009-0658

NCT ID:

NCT01143779

Start Date:

June 2010

Completion Date:

Related Keywords:

  • Advanced Cancer
  • Advanced Malignancy
  • FLT-PET Scan
  • [F-18]-fluoro-L-thymidine
  • FLT
  • Positron emission tomography
  • PET
  • Imaging Biomarker
  • Temsirolimus
  • Topotecan
  • Bortezomib
  • Neoplasms

Name

Location
University of Texas MD Anderson Cancer Center Houston, Texas  77030