Clinical Trials

MainTitle

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

This study is ongoing, but not recruiting participants.
Sponsor
Navidea Biopharmaceuticals

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

Information provided by (Responsible Party)
Navidea Biopharmaceuticals
ClinicalTrials.gov Identifier
NCT03157167

First received: May 4, 2017
Last updated: March 5, 2020
Last Verified: March 2020
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
Kaposi Sarcoma
HIV Infections

Drug : Tc99m-tilmanocept
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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)

Further study details as provided by Navidea Biopharmaceuticals:

Primary Outcome Measures

  • 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).
Secondary Outcome Measures:
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Enrollment: 14
Study Start Date: December 1, 2017
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: November 5, 2019 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Lymphoseek

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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.

      contacts and locations

      Contacts and Locations

      Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

      Please refer to this study by its ClinicalTrials.gov identifier: NCT03157167

      Locations

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

      Sponsors and Collaborators

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

      Investigators

      Study Director: Michael Blue, MD Navidea Biopharmaceuticals
      More Information

      More Information


      Responsible Party: Navidea Biopharmaceuticals  
      ClinicalTrials.gov Identifier: NCT03157167   History of Changes  
      Other Study ID Numbers: NAV3-24  
        1R44CA192859-01  
      Study First Received: May 4, 2017  
      Last Updated: March 5, 2020  
      Individual Participant Data    
      Plan to Share IPD: No  

      Studies a U.S. FDA-regulated Drug Product: Yes  
      Studies a U.S. FDA-regulated Device Product: No  

      Keywords provided by Navidea Biopharmaceuticals:

      Kaposi Sarcoma, KS, HIV

      Additional relevant MeSH terms:
      Sarcoma, Kaposi
      Sarcoma

      ClinicalTrials.gov processed this data on June 02, 2020
      This information is provided by ClinicalTrials.gov.