124I-FIAU Imaging in EBV and KSHV Associated Cancers - NCT00982449-21287 (Clinical Trial 352225)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy352225.aspx
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| City: |
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Baltimore |
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State:
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MD |
| Zip Code: |
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21287 |
| Conditions: |
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Hodgkin Lymphoma - Non Hodgkin Lymphoma - Kaposi's Sarcoma - Gastric Cancer - Nasopharyngeal Cancer |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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Inclusion Criteria:
- 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 mins. and fit on PET/CT.
- For post-therapy imaging with FIAU-PET, treatment with standard or investigational
agents that can potentially activate herpesvirus TK, including but not limited to:
- Platinum compounds (for example, cisplatin, carboplatin)
- Anthracyclines (for example, doxorubicin or pegylated doxorubicin)
- Tubulin disrupting agents (for example, vincristine, vinblastine)
- Rituximab
- Gemcitabine
- Cytarabine
- Bortezomib
- Histone deacetylase inhibitors
- 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.
Exclusion Criteria:
- 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. |
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| Study is available at: |
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Sidney Kimmel Comprehensive Cancer Center
Baltimore, MD 21287
United States
Primary Contact:
Yvette Kasamon, M.D.
Email: ykasamo1@jhmi.edu
Phone: 410-614-6396 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 17, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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