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124I-FIAU Imaging in EBV and KSHV Associated Cancers

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ClinicalTrials.gov Identifier: NCT00982449
Recruitment Status : Recruiting
First Posted : September 23, 2009
Last Update Posted : May 18, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Description
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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
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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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
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 at Johns Hopkins
National Cancer Institute (NCI)
Investigators
Principal Investigator: Richard Ambinder, M.D. Johns Hopkins University
More Information
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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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    Key Record Dates
Last Update Posted: May 18, 2016
Last Verified: May 2016

Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
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