Status:
COMPLETED
124I-FIAU Imaging in EBV and KSHV Associated Cancers
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Hodgkin Lymphoma
Non Hodgkin Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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 ima...
Detailed Description
EBV and KSHV are associated with a variety of malignancies including some lymphomas, carcinomas and other malignancies. We anticipate that viral TK expression will differ among tumor types and will be...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00982449
Start Date
December 1 2010
End Date
July 1 2013
Last Update
September 17 2018
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21287