124I-FIAU Imaging in EBV and KSHV Associated Cancers

Completed · Not applicable

Conditions studied: Hodgkin Lymphoma, Non Hodgkin Lymphoma, Kaposi's Sarcoma, Gastric Cancer, Nasopharyngeal Cancer

In brief

This research is being done to determine whether viral thymidine kinase (TK) expression in Epstein-Barr virus (EBV) and Kaposi's sarcoma herpesvirus (KSHV) virus-associated tumors is sufficient to image.

Key facts

Study ID

NCT00982449

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

12

Starts

2010-12-01

Expected to finish

2013-07-01

Last updated by the study team

2018-09-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years or older.
• EBV-positive or KSHV-associated malignancy, including but not limited to:
• EBV+ Hodgkin lymphoma
• EBV+ non-Hodgkin lymphoma or lymphoproliferative disease
• Primary effusion lymphoma
• Kaposi's sarcoma
• EBV+ gastric cancer
• EBV+ nasopharyngeal cancer
• Measurable disease (at least one lesion measuring > 2 cm in longest axis).
• ECOG performance status of 0, 1, or 2.
• Patients must be able to lie flat for at least 60 minutes and fit on PET-CT scanner.
• For post-therapy imaging with FIAU-PET, treatment with standard or investigational agents that can potentially activate herpesvirus TK, including but not limited to the following. Concurrent radiation therapy is permissible:
• Platinum compounds (for example, cisplatin, carboplatin)
• Anthracyclines (for example, doxorubicin or pegylated doxorubicin)
• Tubulin disrupting agents (for example, vincristine, vinblastine)
• Rituximab
• Gemcitabine
• Cytarabine
• Histone deacetylase inhibitors
• Bortezomib NOTE: Patients who would not receive bortezomib as part of their usual care may receive a one-time dose of bortezomib for the purpose of imaging with 124I-FIAU and FIAU-PET-CT.
• AST and ALT < 3 X upper limit of normal, unless attributed to tumor, obtained within 2 weeks prior to registration.
• Serum creatinine < 2.0 mg/dL, within 2 weeks prior to registration.
• In patients who will receive bortezomib for imaging purposes only:
• Total bilirubin < 1.5 X upper limit of normal, obtained within 2 weeks prior to registration.
• Platelet count > 70,000 / mm3 obtained within 2 weeks prior to registration.

You may not qualify if…

• End-stage liver disease unrelated to tumor.
• Known active or chronic hepatitis B or hepatitis C infection.
• History of iodine hypersensitivity.
• Chronic renal insufficiency requiring dialysis.
• Women who are pregnant or breast feeding.
• Foreseen inability to comply with study requirements.

Where it is running

• Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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