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

Phase 0
18 Years
75 Years
Open (Enrolling)
Hodgkin Lymphoma, Non Hodgkin Lymphoma, Kaposi's Sarcoma, Gastric Cancer, Nasopharyngeal Cancer

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Trial Information

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

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

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

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.

Outcome Time Frame:

Baseline, Days 1-3 post chemo

Safety Issue:


Principal Investigator

Yvette Kasamon, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins University


United States: Institutional Review Board

Study ID:




Start Date:

June 2010

Completion Date:

December 2015

Related Keywords:

  • Hodgkin Lymphoma
  • Non Hodgkin Lymphoma
  • Kaposi's Sarcoma
  • Gastric Cancer
  • Nasopharyngeal Cancer
  • 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
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Stomach Neoplasms
  • Sarcoma, Kaposi
  • Nasopharyngeal Neoplasms
  • Sarcoma



Sidney Kimmel Comprehensive Cancer Center Lutherville, Maryland