124I-FIAU Imaging in EBV and KSHV Associated Cancers

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Hodgkin Lymphoma; Non Hodgkin Lymphoma; Kaposi's Sarcoma; Gastric Cancer; Nasopharyngeal Cancer	Other: FIAU-PET-CT scans; Other: FIAU-PET-CT scan	Early Phase 1

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.

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	15 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Basic Science
Official Title:	Study of Imaging of Viral Thymidine Kinase Activity in EBV-Associated and KSHV-Associated Malignancies
Study Start Date :	June 2010
Estimated Primary Completion Date :	December 2017
Estimated Study Completion Date :	December 2018

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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: FIAU; I-FIAU; PET-CT; FIAU-PET-CT
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: FIAU; I-FIAU; PET-CT; FIAU-PET-CT

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 Measures :

1. 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 ]

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00982449 History of Changes
Other Study ID Numbers:	J09111; NA_00032681 ( Other Identifier: JHMIRB ); P01CA015396 ( U.S. NIH Grant/Contract )
First Posted:	September 23, 2009
Last Update Posted:	May 18, 2016
Last Verified:	May 2016

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