An Evaluation of Tc 99m Tilmanocept by Intravenous (IV) and Subcutaneous (SC) Injection in Kaposi Sarcoma (KS)

July 14, 2020 updated by: Navidea Biopharmaceuticals

An Evaluation of the Safety of Escalating Doses of Tc 99m Tilmanocept by Intravenous (IV) Injection and a Comparison to Subcutaneous (SC) Injection in Human Immunodeficiency Virus (HIV) Subjects Diagnosed With Kaposi Sarcoma (KS)

To determine the safety of escalating IV doses of Tc 99m tilmanocept in HIV (human immunodeficiency virus) subjects with confirmed KS and to compare results obtained from subcutaneous and IV administrations of Tc 99m tilmanocept in the same subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a Manocept Platform prospective, single-center, open-label, non-randomized, dose escalation, comparative, safety study of intravenously and subcutaneously injected Tc 99m tilmanocept in the localization and detection of cutaneous and non-cutaneous KS tumor(s) in subjects with biopsy-confirmed KS. Three IV doses (µg/mCi) of tilmanocept will be evaluated in three cohort groups. One subcutaneous dose will be evaluated in cohort group 3.

This study is designed to evaluate the safety and tolerability of escalating doses of IV Tc 99m tilmanocept and to compare results obtained from IV and subcutaneous administrations of Tc 99m tilmanocept in the same subjects. Whole body planar as well as SPECT/CT imaging will be performed to provide greater resolution of areas of Tc 99m tilmanocept localization. A biopsy of a non-visceral KS lesion will be taken to correlate pathology with Tc 99m tilmanocept localization.

This study is designed to evaluate the use of Tc 99m tilmanocept as an imaging agent in HIV-positive subjects with known KS by evaluating localization in known and unknown cutaneous and non-cutaneous lesions.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • Zuckerberg San Francisco General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. The subject has provided written informed consent with HIPAA authorization before the initiation of any study-related procedures.
  2. The subject is at least 18 years of age at the time of consent.
  3. The subject is HIV positive.

  4. The subject has a biopsy-confirmed diagnosis of KS and is classified into one of the categories below:

    1. Confirmed cutaneous KS/oral lesions without edema.
    2. Confirmed cutaneous KS/oral lesions with edema.
    3. Confirmed cutaneous KS/oral lesions with or without edema and suspected non-cutaneous KS due to clinical symptomology or confirmed non-cutaneous KS lesion(s).

Exclusion Criteria:

  1. The subject is pregnant or lactating.
  2. The subject has received chemotherapy or radiation therapy to KS sites within six weeks of enrollment.
  3. The subject has known sensitivity to dextran.
  4. The subject has received an investigational product within 30 days prior to the Tc 99m tilmanocept administration on Day 1.
  5. The subject has received any radiopharmaceutical within 7 days prior to the administration of Tc 99m tilmanocept on Day 1.
  6. Any condition that, in the clinical judgment of the treating physician, is likely to prevent the subject from complying with any aspect of the protocol or that may put the subject at unacceptable risk.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 100 mcg/5 mCi Tc99m-Tilmanocept
Four subjects will receive a single IV injection of 100 micrograms of Tc99m tilmanocept radiolabeled with 5 mCi.
Drug: Tc99m-tilmanocept
Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
Other Names:
  • Lymphoseek
Experimental: 100 mcg/10 mCi Tc99m-Tilmanocept
Four subjects will receive a single IV injection of 100 micrograms of Tc99m tilmanocept radiolabeled with 10 mCi.
Drug: Tc99m-tilmanocept
Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
Other Names:
  • Lymphoseek
Experimental: 200 mcg/5 mCi Tc99m-Tilmanocept
Up to six subjects will receive a single subcutaneous injection and a single IV injection of 200 micrograms of Tc99m tilmanocept radiolabeled with 5 mCi.
Drug: Tc99m-tilmanocept
Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
Other Names:
  • Lymphoseek

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Drug Reaction
Time Frame: 7 days after IV Tc 99m tilmanocept administration
Proportion of subjects experiencing noxious pharmacologic activity/an Adverse Drug Reaction (ADR).
7 days after IV Tc 99m tilmanocept administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Per Subject Localization
Time Frame: 7 days after IV Tc 99m tilmanocept administration
Per subject localization rate of Tc 99m tilmanocept in at least one KS suspected or confirmed lesion by planar and/or SPECT/CT imaging.
7 days after IV Tc 99m tilmanocept administration
Localization concordance with physical observations
Time Frame: 7 days after IV Tc 99m tilmanocept administration
Per lesion/region concordance of Tc 99m localization with anatomical areas of active KS defined by confirmed diagnosis or clinical symptomology.
7 days after IV Tc 99m tilmanocept administration
Localization Intensity
Time Frame: 7 days after IV Tc 99m tilmanocept administration
Localization intensity for each biopsied and clinically defined lesion, as determined by quantitative SPECT gamma counts.
7 days after IV Tc 99m tilmanocept administration
Per subject localization
Time Frame: 7 days after IV Tc 99m tilmanocept administration
Per subject localization rate of Tc 99m tilmanocept in areas other than KS by planar and/or SPECT/CT imaging.
7 days after IV Tc 99m tilmanocept administration
Per area localization rate
Time Frame: 7 days after IV Tc 99m tilmanocept administration
Per area localization rate of Tc 99m tilmanocept in the most frequently identified areas other than KS by planar and/or SPECT CT imaging.
7 days after IV Tc 99m tilmanocept administration
Biopsy analyses
Time Frame: 7 days after IV Tc 99m tilmanocept administration
Per biopsied lesion proportion of CD206-expressing cells and total CD206, as determined by histology and relative IHC fluorescence.
7 days after IV Tc 99m tilmanocept administration
Localization concordance of subcutaneous injection and IV injection
Time Frame: 7 days after IV Tc 99m tilmanocept administration
Per lesion/region concordance of IV vs subcutaneous Tc 99m localization with anatomical areas of active KS defined by confirmed diagnosis or clinical symptomology.
7 days after IV Tc 99m tilmanocept administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Navidea Biopharmaceuticals

Collaborators

National Cancer Institute (NCI)
National Institutes of Health (NIH)

Investigators

  • Study Director: Michael Blue, MD, Navidea Biopharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Actual)

November 5, 2019

Study Completion (Actual)

March 30, 2020

Study Registration Dates

First Submitted

May 4, 2017

First Submitted That Met QC Criteria

May 16, 2017

First Posted (Actual)

May 17, 2017

Study Record Updates

Last Update Posted (Actual)

July 16, 2020

Last Update Submitted That Met QC Criteria

July 14, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAV3-24
  • 1R44CA192859-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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