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124I-FIAU Imaging in EBV and KSHV Associated Cancers

This study is currently recruiting participants.
Verified January 2013 by Sidney Kimmel Comprehensive Cancer Center
Sponsor:
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: January 14, 2013
Last verified: January 2013
History of Changes
  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:

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 2015
Estimated Primary Completion Date: December 2014 (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:
  • 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

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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00982449

Contacts
Contact: Yvette Kasamon, M.D. 410-614-6396 ykasamo1@jhmi.edu
Contact: Richard Ambinder, M.D., Ph.D. 410-955-8839 AMBINRI@jhmi.edu

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Yvette Kasamon, M.D     410-955-8839     ykasamo1@jhmi.edu    
Principal Investigator: Yvette Kasamon, M.D.            
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Yvette Kasamon, M.D. Johns Hopkins University
  More Information

No publications provided

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: January 14, 2013
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:
Hodgkin Disease
Lymphoma
Lymphoma, Non-Hodgkin
Stomach Neoplasms
Sarcoma, Kaposi
Nasopharyngeal Neoplasms
Sarcoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Neoplasms, Connective and Soft Tissue
Neoplasms, Vascular Tissue
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 22, 2013