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124I-FIAU Imaging in EBV and KSHV Associated Cancers

Primary Purpose

Hodgkin Lymphoma, Non Hodgkin Lymphoma, Kaposi's Sarcoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FIAU-PET-CT-2
FIAU-PET-CT-4
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hodgkin Lymphoma focused on measuring 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

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sidney Kimmel Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

4 mCi of I-FIAU

2 mCi of I-FIAU

Arm Description

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.

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.

Outcomes

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.

Secondary Outcome Measures

To describe changes in viral DNA in plasma as a function of chemotherapy and the association with imaging by FIAU-PET

Full Information

First Posted
September 22, 2009
Last Updated
September 13, 2018
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00982449
Brief Title
124I-FIAU Imaging in EBV and KSHV Associated Cancers
Official Title
Study of Imaging of Viral Thymidine Kinase Activity in EBV-Associated and KSHV-Associated Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
December 2010 (Actual)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Lymphoma, Non Hodgkin Lymphoma, Kaposi's Sarcoma, Gastric Cancer, Nasopharyngeal Cancer
Keywords
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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
4 mCi of I-FIAU
Arm Type
Active Comparator
Arm Description
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.
Arm Title
2 mCi of I-FIAU
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
FIAU-PET-CT-2
Other Intervention Name(s)
FIAU, I-FIAU, PET-CT, FIAU-PET-CT
Intervention Description
1-3 days after chemotherapy, subject get I-FIAU 2 mCi, then have FIAU-PET-CT done 2 - 4 hours after I-FIAU
Intervention Type
Other
Intervention Name(s)
FIAU-PET-CT-4
Other Intervention Name(s)
FIAU, I-FIAU, PET-CT, FIAU-PET-CT
Intervention Description
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
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years or older. 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 Measurable disease (at least one lesion measuring > 2 cm in longest axis). ECOG performance status of 0, 1, or 2. Patients must be able to lie flat for at least 60 minutes and fit on PET-CT scanner. 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. AST and ALT < 3 X upper limit of normal, unless attributed to tumor, obtained within 2 weeks prior to registration. Serum creatinine < 2.0 mg/dL, within 2 weeks prior to registration. 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: End-stage liver disease unrelated to tumor. Known active or chronic hepatitis B or hepatitis C infection. History of iodine hypersensitivity. Chronic renal insufficiency requiring dialysis. Women who are pregnant or breast feeding. Foreseen inability to comply with study requirements.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Ambinder, M.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sidney Kimmel Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

124I-FIAU Imaging in EBV and KSHV Associated Cancers

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