124I-FIAU Imaging in EBV and KSHV Associated Cancers - Tabular View

Tracking Information

First Received Date ^ICMJE

September 22, 2009

Last Updated Date

September 24, 2009

Start Date ^ICMJE

November 2009

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00982449 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

124I-FIAU Imaging in EBV and KSHV Associated Cancers

Official Title ^ICMJE

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

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.

Study Phase

Phase 0

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Non-Randomized
Control:  Dose Comparison
Endpoint Classification:  Bio-equivalence Study
Intervention Model:  Single Group Assignment
Masking:  Open Label
Primary Purpose:  Basic Science

Condition ^ICMJE

Hodgkin Lymphoma
Non Hodgkin Lymphoma
Kaposi's Sarcoma
Gastric Cancer
Nasopharyngeal Cancer

Intervention ^ICMJE

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

Study Arms / Comparison Groups

4 mCi of I-FIAU: Active Comparator
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
2 mCi of I-FIAU: Active Comparator
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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2014

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 mins. and fit on PET/CT.
For post-therapy imaging with FIAU-PET, treatment with standard or investigational agents that can potentially activate herpesvirus TK, including but not limited to:
- Platinum compounds (for example, cisplatin, carboplatin)
- Anthracyclines (for example, doxorubicin or pegylated doxorubicin)
- Tubulin disrupting agents (for example, vincristine, vinblastine)
- Rituximab
- Gemcitabine
- Cytarabine
- Bortezomib
- Histone deacetylase inhibitors
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.

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.

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00982449

Responsible Party

Yvette Kasamon, M.D., Sidney Kimmel Comprehensive Cancer Center

Study ID Numbers ^ICMJE

J09111, NA_00032681

Study Sponsor ^ICMJE

Sidney Kimmel Comprehensive Cancer Center

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Principal Investigator:

Yvette Kasamon, M.D.

Johns Hopkins University

Information Provided By

Sidney Kimmel Comprehensive Cancer Center

Verification Date

September 2009

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