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| ID | Type | Description | Link |
|---|---|---|---|
| NA_00032681 | Other Identifier | JHMIRB | |
| P01CA015396 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4 mCi of I-FIAU | Active Comparator | 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. |
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| 2 mCi of I-FIAU | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FIAU-PET-CT-2 | Other | 1-3 days after chemotherapy, subject get I-FIAU 2 mCi, then have FIAU-PET-CT done 2 - 4 hours after I-FIAU |
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| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Age 18 years or older.
EBV-positive or KSHV-associated malignancy, including but not limited to:
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:
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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Ambinder, M.D. | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland | 21287 | United States |
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| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| D008228 | Lymphoma, Non-Hodgkin |
| D012514 | Sarcoma, Kaposi |
| D013274 | Stomach Neoplasms |
| D009303 | Nasopharyngeal Neoplasms |
| D054685 | Lymphoma, Primary Effusion |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| C043457 | fialuridine |
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| FIAU-PET-CT-4 | Other | 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 |
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| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D012509 | Sarcoma |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009383 | Neoplasms, Vascular Tissue |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D016393 | Lymphoma, B-Cell |