124I-FIAU Imaging in EBV and KSHV Associated Cancers

NCT ID: NCT00982449

Last Updated: 2018-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2013-07-31

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

FIAU-PET-CT-4

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

FIAU-PET-CT-2

Intervention Type: OTHER

1-3 days after chemotherapy, subject get I-FIAU 2 mCi, then have FIAU-PET-CT done 2 - 4 hours after I-FIAU

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

Other Intervention Names

FIAU; I-FIAU; PET-CT; FIAU-PET-CT; FIAU; I-FIAU; PET-CT; FIAU-PET-CT

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Ambinder, M.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA_00032681

Identifier Type: OTHER

Identifier Source: secondary_id

P01CA015396

Identifier Type: NIH

Identifier Source: secondary_id

View Link

J09111

Identifier Type: -

Identifier Source: org_study_id