124I-FIAU Imaging in EBV and KSHV Associated Cancers

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Sidney Kimmel Comprehensive Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00982449
First received: September 22, 2009
Last updated: March 23, 2014
Last verified: March 2014

September 22, 2009
March 23, 2014
June 2010
December 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00982449 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
124I-FIAU Imaging in EBV and KSHV Associated Cancers
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.

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.

Interventional
Phase 0
Allocation: Non-Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Hodgkin Lymphoma
  • Non Hodgkin Lymphoma
  • Kaposi's Sarcoma
  • Gastric Cancer
  • Nasopharyngeal Cancer
  • 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
  • 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: 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.
    Intervention: Other: FIAU-PET-CT scan
  • 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.
    Intervention: Other: FIAU-PET-CT scans
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
December 2016
December 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact: Yvette Kasamon, M.D. 410-614-6396 ykasamo1@jhmi.edu
Contact: Richard Ambinder, M.D., Ph.D. 410-955-8839 AMBINRI@jhmi.edu
United States
 
NCT00982449
J09111, NA_00032681, P01CA015396
No
Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Yvette Kasamon, M.D. Johns Hopkins University
Sidney Kimmel Comprehensive Cancer Center
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP