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)

Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• The subject has provided written informed consent with HIPAA authorization before the initiation of any study-related procedures.

• The subject is at least 18 years of age at the time of consent.

• The subject is HIV positive.

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

‣ Confirmed cutaneous KS/oral lesions without edema.

⁃ Confirmed cutaneous KS/oral lesions with edema.

⁃ 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).

Locations
United States
California
Zuckerberg San Francisco General Hospital
San Francisco
Time Frame
Start Date: 2017-12-01
Completion Date: 2020-03-30
Participants
Target number of participants: 14
Treatments
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.
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.
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.
Authors
Fred Cope, Toby A Maurer
Sponsors
Leads: Navidea Biopharmaceuticals
Collaborators: National Institutes of Health (NIH), National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov