124I-FIAU Imaging in EBV and KSHV Associated Cancers

September 13, 2018 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study of Imaging of Viral Thymidine Kinase Activity in EBV-Associated and KSHV-Associated Malignancies

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Sidney Kimmel Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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-4.
Other: FIAU-PET-CT-4
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:
  • PET-CT
  • FIAU
  • I-FIAU
  • 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-2.
Other: FIAU-PET-CT-2
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:
  • PET-CT
  • FIAU
  • I-FIAU
  • FIAU-PET-CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: Baseline, Days 1-3 post chemo
Baseline, Days 1-3 post chemo

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Baseline, pre chemo, post chemo, day 8 post chemo

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: RIchard Ambinder, M.D., Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2010

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

September 22, 2009

First Submitted That Met QC Criteria

September 22, 2009

First Posted (Estimate)

September 23, 2009

Study Record Updates

Last Update Posted (Actual)

September 17, 2018

Last Update Submitted That Met QC Criteria

September 13, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • J09111
  • P01CA015396 (U.S. NIH Grant/Contract)
  • NA_00032681 (Other Identifier: JHMIRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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