MDACC Study Summary 2008-0106

Study Summary
No. 2008-0106:.......Advanced Cancers......Sarina Piha-Paul......Investigational Cancer Therapeutics

Study Summary Title



Study Summary Number:	2008-0106

Study Title:	Early Prediction of Clinical Response to Chemotherapy with FLT-PET

Physician

New Patient Referral



Name:	Sarina Piha-Paul	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Investigational Cancer Therapeutics	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-563-0181 Contact us about clinical trials

General Information



Disease Group:	Advanced Cancers	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Day 1, 8, and 15 every 21 days.

Treatment Agents:	FLT-PET	Home Care:	Not applicable.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	Not applicable.


Description/ Intervention:	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.

Study Objectives / Outcomes

1.1 Primary objective:

1.1.1 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.

1.2 Secondary objective:

1.2.1 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.

Study Status Information



Study Activation / Registration Date:	04/09/2009

IRB Review and Approval Date:	04/09/2009

Study Type:	Other

Recruitment Status:	Open

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) 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. For details please see Appendix G.

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) Participants must be 18 years of age or older.

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.

Links

Registration Number: NCT00880074
Study Information on Clinical Trials Registry (clinicaltrials.gov)