FLT-PET in Predicting Response to Chemotherapy in Patient... | NCT00880074

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

NCT00880074

Sponsor

M.D. Anderson Cancer Center

Status

Completed

Last Update Posted

Jun 26, 2023Actual

Enrollment

10Actual

Phase

Phase 1

Conditions

Malignant Neoplasm

Interventions

Fluorothymidine F-18
Laboratory Biomarker Analysis
Positron Emission Tomography

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description
NCI-2012-01625	Registry Identifier	CTRP (Clinical Trial Reporting Program)
NCI-2010-01046
2008-0106	Other Identifier	M D Anderson Cancer Center
NCI-2012-01625	Other Identifier	NCI-CTRP Clinical Trials Registry

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 9, 2009Actual

Primary Completion Date

Feb 4, 2022Actual

Completion Date

Feb 4, 2022Actual

First Submitted Date

Apr 9, 2009

First Submission Date that Met QC Criteria

Apr 10, 2009

First Posted Date

Apr 13, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2023

Last Update Posted Date

Jun 26, 2023Actual

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diagnostic (fluorine F-18 fluorothymidine PET)	Experimental	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 Other: Laboratory Biomarker Analysis Procedure: Positron Emission Tomography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fluorothymidine F-18	Drug	Undergo fluorine F-18 fluorothymidine PET	Diagnostic (fluorine F-18 fluorothymidine PET)

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Sarina A Piha-Paul	M.D. Anderson Cancer Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
M D Anderson Cancer Center		Houston	Texas	77030	United States

Label	URL
M D Anderson Cancer Center	View source

ID	Term
D009369	Neoplasms

Intervention Browse Module

MeSH Terms

ID	Term
C002854	alovudine
D009682	Magnetic Resonance Spectroscopy

Ancestor Terms

ID	Term
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques

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Browse Branches

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