18F FLT Imaging Studies of Treatment Response for Lung Cancer and Thymoma

Background:

- (18)F FLT, a thymidine analog, has uptake in tumors that correlates with proliferative
rates and may be an early predictor of tumor response.

- Due to uptake in inflammatory tissues, routinely used (18)F FDG PET/CT is often unable
to distinguish therapeutic response from reactive change early in therapy.

- Molecularly targeted therapies relating to the MEK kinase pathway in non small cell
lung cancer (NSCLC) and the IGF pathway (anti-IGF-1R monoclonal antibodies) in thymoma,
affect tumor proliferation.

- We intend to explore the potential utility of (18)F FLT PET/CT imaging as an early
marker of therapeutic response in molecularly targeted therapies relating to the MEK
kinase pathway in NSCLC and the IGF pathway in thymic tumors.

Objectives:

-To explore the relationship between change in (18)F FLT tumor uptake (pre-treatment and
soon after initiation of treatment (2 weeks)) and progression free survival in NSCLC
patients treated with AZD6244 and in thymoma patients with IMC-A12, Cixutumumab

Eligibility:

- Subjects with pathology proven lung cancer or thymoma enrolled in an NCI therapy
protocol.

- Participant must be 18 years or older and have ECOG Performance of less than or equal
to 2.

- Patients must have measurable disease by RECIST criteria.

- Patients must have the ability to provide informed consent. All subjects must sign a
document of informed consent indicating their understanding of the investigational
nature and risks of the study before any protocol related studies are performed.

Design:

-This is a pilot study which will incorporate (18)F FLT and (18)F FDG PET/CT imaging
sessions prior to therapy with AZD6244, Selumetinib, in NSCLC and IMC-A12, Cixutumumab, in
thymoma, and 2 weeks (+/- 4 days) following therapy initiation. The imaging parameters will
be evaluated with respect to clinical response (as determined under the referring protocol).
We expect to enroll 24 evaluable patients in this single center study.

- INCLUSION CRITERIA:

- Subjects with pathology proven lung cancer or thymic malignancy already enrolled in
an NCI treatment protocol usingAZD6244 in NSCLC and IMC-A12, in thymoma.

- Participant must be 18 years or older

- ECOG Performance score of 0 to 2

- Ability to provide informed consent. All patients must sign a document of informed
consent indicating their understanding of the investigational nature and risks of
this study before any protocol related studies are performed.

- Participants must NOT be pregnant or intend to become pregnant within 1 week of the
last injection of (18)F FLT

EXCLUSION CRITERIA:

- Known allergy to fluorothymidine

- Participants for whom enrollment would significantly delay (> 2 weeks) the scheduled
standard of care therapy

- Participants with any coexisting medical or psychiatric condition that is likely to
interfere with study procedures and/or results are excluded

- Participants with severe claustrophobia not relieved by oral anxiolytic medication or
patients weighing > 136 kg (weight limit for scanner table)

- Other medical conditions deemed by the PI or associates to make the patient
ineligible for protocol procedures