124I-FIAU Imaging in EBV and KSHV Associated Cancers

Study of Imaging of Viral Thymidine Kinase Activity in EBV-Associated and KSHV-Associated Malignancies

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00982449

Enrollment

Registered

2009-09-23

Start date

2010-12-31

Completion date

2013-07-31

Last updated

2018-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer, Hodgkin Lymphoma, Kaposi's Sarcoma, Nasopharyngeal Cancer, Non Hodgkin Lymphoma

Keywords

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

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 image.

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 adjusted with standard chemotherapies and some investigational agents. This exploratory study is aimed in part at evaluating whether standard regimens or investigational regimens might bring about sufficient activation of the EBV-TK or KSHV-TK in tumors to be therapeutically useful if used in conjunction with FIAU as a radiopharmaceutical.

Interventions

OTHERFIAU-PET-CT-2

1-3 days after chemotherapy, subject get I-FIAU 2 mCi, then have FIAU-PET-CT done 2 - 4 hours after I-FIAU

OTHERFIAU-PET-CT-4

1-3 days after any chemotherapy that may activate viral TK, 4 mCi, rather than 2 mCi, of I-FIAU are administered, followed 2 - 4 hours later by FIAU-PET-CT

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Age 18 years or older. 2. 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 3. Measurable disease (at least one lesion measuring \> 2 cm in longest axis). 4. ECOG performance status of 0, 1, or 2. 5. Patients must be able to lie flat for at least 60 minutes and fit on PET-CT scanner. 6. 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. 7. AST and ALT \< 3 X upper limit of normal, unless attributed to tumor, obtained within 2 weeks prior to registration. 8. Serum creatinine \< 2.0 mg/dL, within 2 weeks prior to registration. 9. 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

1. End-stage liver disease unrelated to tumor. 2. Known active or chronic hepatitis B or hepatitis C infection. 3. History of iodine hypersensitivity. 4. Chronic renal insufficiency requiring dialysis. 5. Women who are pregnant or breast feeding. 6. Foreseen inability to comply with study requirements.

Design outcomes

Primary

Measure	Time frame
To evaluate the potential for enzymatic targeting as evidenced by the ability to image 124I-FIAU tracer uptake in tumor at baseline and following chemotherapy or biologic therapy with agents that may induce viral TK activation.	Baseline, Days 1-3 post chemo

Secondary

Measure	Time frame
To describe changes in viral DNA in plasma as a function of chemotherapy and the association with imaging by FIAU-PET	Baseline, pre chemo, post chemo, day 8 post chemo

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026