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

Early Prediction of Clinical Response to Chemotherapy With FLT-PET

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00880074

Enrollment

Registered

2009-04-13

Start date

2009-04-09

Completion date

2022-02-04

Last updated

2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Neoplasm

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.

Interventions

DRUGFluorothymidine F-18

Undergo fluorine F-18 fluorothymidine PET

OTHERLaboratory Biomarker Analysis

Optional correlative studies

PROCEDUREPositron Emission Tomography

Undergo fluorine F-18 fluorothymidine PET

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026