124I-FIAU Imaging in EBV and KSHV Associated Cancers
Hodgkin Lymphoma, Non Hodgkin Lymphoma, Kaposi's Sarcoma
About this trial
This is an interventional basic science trial for Hodgkin Lymphoma focused on measuring EBV+ malignancies, KSHV+ malignancies, HIV-associated lymphomas, Hodgkin Lymphoma, nonHodgkin Lymphoma or, nonHodgkins Lymphoproliferative Disease, Primary Effusion Lymphoma, Kaposi's Sarcoma, Gastric Cancer, Nasopharyngeal Cancer
Eligibility Criteria
Inclusion Criteria:
- 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.
- No pre-existing peripheral neuropathy greater than grade 1.
Exclusion Criteria:
- 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.
Sites / Locations
- Sidney Kimmel Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
4 mCi of I-FIAU
2 mCi of I-FIAU
GROUP B 1-3 days after any chemotherapy that may activate viral TK, 4 mCi of I-FIAU are administered, followed 2 - 4 hours later by FIAU-PET-CT-4.
GROUP A 1-3 days after any chemotherapy that may activate viral TK, 2 mCi of I-FIAU are administered, followed 2 - 4 hours later by FIAU-PET-CT-2.