Penn Vet | Mason Clinical Trial - Evaluation of Nemo Binding Domain (NBD) peptide for dogs with soft tissue sarcoma

Mason Immunotherapy Research Trials


Evaluation of Nemo Binding Domain (NBD) peptide for dogs with soft tissue sarcoma

Nov 12, 2019

Purpose:

  • To investigating whether NBD peptide can promote tumor cell death in canine soft tissue sarcomas (STS) that have active NF-KB (signaling pathway) activity

Eligibility criteria:

  • Confirmed/highly suspected diagnosis of STS obtained either via FNA or biopsy
  • Dog is otherwise healthy
  • No evidence of pulmonary metastasis

Basic study design:

  • Screening visit - staging (blood work, urinalysis, chest x-rays) + incisional biopsy of the mass (to confirm diagnosis of sarcoma and also to determine whether the NF-KB pathway is overactive in the mass)
  • If the overactive pathway is identified, then within one week:
    • Daily tumor injections for 4 days with the NBD peptide (outpatient procedure)
    • On day 5, the tumor is removed via definitive surgical excision (or if it is nonresectable, a second incisional biopsy will be obtained).
  • Following surgery - recheck visits every 2 months for a total of 3 visits (physical exam and chest x-rays).

Covered costs:

  • Physical examinations throughout the course of the study.
  • General health blood and urine tests at screening and one day after the last NBD peptide administration.
  • Chest x-rays at screening and every 2 months there-after for a total of 6 months.
  • Two biopsies of the tumor performed under light sedation or general anesthetic.
  • Immunohistochemical analysis of the tumor (to determine NF-kappaB expression).
  • $300 towards definitive surgery (to be performed one day following the last NBD peptide administration. This would replace the second biopsy procedure)
  • Treatment of any toxicity your dog develops secondary to NBD peptide administration.

 

Please contact the VCIC at 215-573-0302 or vcic@vet.upenn.edu for more information about this study.