124I-FIAU Imaging in EBV and KSHV Associated Cancers

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00982449
• Date of registration: 22/09/2009
• Prospective Registration: Yes
• Primary sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Public title: 124I-FIAU Imaging in EBV and KSHV Associated Cancers
• Scientific title: Study of Imaging of Viral Thymidine Kinase Activity in EBV-Associated and KSHV-Associated Malignancies
• Date of first enrolment: December 2010
• Target sample size: 12
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00982449
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Richard Ambinder, M.D.
• Affiliation: Johns Hopkins University

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Non Hodgkin Lymphoma

Kaposi's Sarcoma

Nasopharyngeal Cancer

Hodgkin Lymphoma

Gastric Cancer

Intervention(s)

Other: FIAU-PET-CT-2

Other: FIAU-PET-CT-4

Primary Outcome(s)

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. [Time Frame: Baseline, Days 1-3 post chemo]

Secondary Outcome(s)

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

Secondary ID(s)

NA_00032681

P01CA015396

J09111

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)