FLT-PET as an Imaging Biomarker With Temsirolimus, Topotecan, and Bortezomib

• Status: Active, not recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Bortezomib; Everolimus; Sirolimus; Telbivudine; Topotecan

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.