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

• Status: Completed
• Trial end date: 2020-03-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Navidea Biopharmaceuticals
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)

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.