124I-FIAU Imaging in EBV and KSHV Associated Cancers
This study is currently recruiting participants.
(see Contacts and Locations)
Verified May 2016 by Sidney Kimmel Comprehensive Cancer Center
Sponsor:
Sidney Kimmel Comprehensive Cancer Center
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00982449
First received: September 22, 2009
Last updated: May 17, 2016
Last verified: May 2016
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hodgkin Lymphoma Non Hodgkin Lymphoma Kaposi's Sarcoma Gastric Cancer Nasopharyngeal Cancer |
Other: FIAU-PET-CT scans Other: FIAU-PET-CT scan |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Study of Imaging of Viral Thymidine Kinase Activity in EBV-Associated and KSHV-Associated Malignancies |
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources:
Lymphosarcoma
Primary Effusion Lymphoma
Malignant Mesenchymal Tumor
Soft Tissue Sarcoma
Nasopharyngeal Carcinoma
Stomach Cancer
Hodgkin Lymphoma
Kaposi Sarcoma
Lymphoma AIDS Related
U.S. FDA Resources
Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 15 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | December 2018 |
| Estimated Primary Completion Date: | December 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 4 mCi of I-FIAU
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.
|
Other: FIAU-PET-CT scan
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
Other Names:
|
|
Active Comparator: 2 mCi of I-FIAU
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.
|
Other: FIAU-PET-CT scans
1-3 days after chemotherapy, subject get I-FIAU 2 mCi, then have FIAU-PET-CT done 2 - 4 hours after I-FIAU
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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 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:
- 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.
- 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:
- 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:
- 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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00982449
Please refer to this study by its ClinicalTrials.gov identifier: NCT00982449
Contacts
| Contact: Richard Ambinder, M.D. | 410-955-8839 | rambind1@jhmi.edu |
Locations
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center | Recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Contact: Richard Ambinder, M.D 410-955-8839 rambind1@jhmi.edu | |
| Principal Investigator: Richard Ambinder, M.D. | |
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Richard Ambinder, M.D. | Johns Hopkins University |
More Information
| Responsible Party: | Sidney Kimmel Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00982449 History of Changes |
| Other Study ID Numbers: | J09111 NA_00032681 P01CA015396 |
| Study First Received: | September 22, 2009 |
| Last Updated: | May 17, 2016 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
|
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 |
Additional relevant MeSH terms:
|
Lymphoma Sarcoma Lymphoma, Non-Hodgkin Stomach Neoplasms Hodgkin Disease Sarcoma, Kaposi Nasopharyngeal Neoplasms Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Neoplasms, Connective and Soft Tissue Gastrointestinal Neoplasms |
Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Herpesviridae Infections DNA Virus Infections Virus Diseases Neoplasms, Vascular Tissue Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Nasopharyngeal Diseases Pharyngeal Diseases Stomatognathic Diseases |
ClinicalTrials.gov processed this record on September 23, 2016