FLT-PET in Predicting Response to Chemotherapy in Patients With Advanced Malignancies

Study Overview
=================
Brief Summary
-----------------
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.

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.

Official Title
-----------------
Early Prediction of Clinical Response to Chemotherapy With FLT-PET

Conditions
-----------------
Malignant Neoplasm

Intervention / Treatment
-----------------
* Drug: Fluorothymidine F-18
* Other: Laboratory Biomarker Analysis
* Procedure: Positron Emission Tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (fluorine F-18 fluorothymidine PET)<br>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. | Drug: Fluorothymidine F-18<br>* Undergo fluorine F-18 fluorothymidine PET<br>* Other names: Fluorothymidine F 18;Other: Laboratory Biomarker Analysis<br>* Optional correlative studies<br>Procedure: Positron Emission Tomography<br>* Undergo fluorine F-18 fluorothymidine PET<br>* Other names: PT;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to Chemotherapy Shown in FLT-PET Scans |  | through study completion; an average of 1 year. |