NCT00982449

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2009

Completed
1.2 years until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

September 17, 2018

Status Verified

September 1, 2018

Enrollment Period

2.6 years

First QC Date

September 22, 2009

Last Update Submit

September 13, 2018

Conditions

Hodgkin LymphomaNon Hodgkin LymphomaKaposi's SarcomaGastric CancerNasopharyngeal Cancer

Keywords

EBV+ malignanciesKSHV+ malignanciesHIV-associated lymphomasHodgkin LymphomanonHodgkin Lymphoma ornonHodgkins Lymphoproliferative DiseasePrimary Effusion LymphomaKaposi's SarcomaGastric CancerNasopharyngeal Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, Days 1-3 post chemo

Secondary Outcomes (1)

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

    Baseline, pre chemo, post chemo, day 8 post chemo

Study Arms (2)

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-4.

Other: FIAU-PET-CT-4

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-2.

Other: FIAU-PET-CT-2

Interventions

FIAU-PET-CT-2OTHER

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

Also known as: FIAU, I-FIAU, PET-CT, FIAU-PET-CT
2 mCi of I-FIAU
FIAU-PET-CT-4OTHER

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

Also known as: FIAU, I-FIAU, PET-CT, FIAU-PET-CT
4 mCi of I-FIAU

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • +11 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Hodgkin DiseaseLymphoma, Non-HodgkinSarcoma, KaposiStomach NeoplasmsNasopharyngeal NeoplasmsLymphoma, Primary Effusion

Interventions

fialuridine

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSarcomaNeoplasms, Connective and Soft TissueNeoplasms, Vascular TissueGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesLymphoma, B-Cell

Study Officials

  • Richard Ambinder, M.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2009

First Posted

September 23, 2009

Study Start

December 1, 2010

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

September 17, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)