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Experimental treatment for oral squamous cell carcinoma in cats

Phase I study of QR206 (long acting epothilone D) in cats with oral squamous cell carcinoma

Status: Recruiting

Species: Cat

Veterinary Speciality: Oncology

Description

The purpose of this study is to evaluate a new immunotherapy (QR206) for oral cancer that could help both cats and people. With conventional treatment, such as radiation therapy, the average life-expectancy for cats diagnosed with this cancer is less than 6 months with only 10-20% of cats alive 1 year after diagnosis. The ultimate goal is to determine if QR206, given with radiotherapy, will help stop tumor growth or actually shrink tumors by stimulating the immune system to control the cancer.

QR206 slowly delivers a very small amount of Epothilone D (equivalent to 1/20th the maximum tolerated dose from prior clinical trials) from resorbable polymer particles that are injected directly into a tumor. In mice with oral cancer, this therapy induces immune-stimulatory signaling as it kills cells within the treated tumor. We suspect and will test for a similar mechanism of action in cats with oral cancer.

Cats will receive palliative radiation therapy and one treatment with QR206. We will also perform a series of diagnostic tests before, during, and after the treatment to determine how your cat tolerates the treatment and whether it affects the tumor. If your cat’s cancer progresses, your cat develops severe toxicity or declining quality of life, we will perform a final diagnostic evaluation and your participation in the study will be complete. The duration of the full study is 16 weeks.

 

Inclusion Criteria

  • Cats with a diagnosis of OSCC.
  • Cats that have not received radiation or chemotherapy (including Palladia) for treatment of the cancer.
  • The tumor is measurable and accessible.
  • Participation is limited to those clients that can travel to Grafton, MA for all required visits.

Exclusion Criteria

  • Cats with other systemic diseases that are uncontrolled and likely to compromise the ability of the cat to complete treatment (must live >2 months).
  • Tumors that are not readily accessible to biopsy and other procedures.
  • Metastasis to the lungs, thoracic lymph nodes, or distant site; or tumors requiring a treatment field covering >50% of brain or spinal tissue in cross section.

Client Benefits

The study will cover hospital fees, diagnostic testing, QR206 administration and follow-up monitoring, which would normally cost over $6000. Your pet’s participation will also allow us to gain information about QR206 treatment for OSCC in cats, which could lead to a new treatment for both cats and people affected by this cancer.

The QR206 therapy being tested in this study is experimental and may not alleviate or cure your cat’s ailment. Except for the specific financial support described here, any tests or procedures unrelated to this study including treatment of conditions unrelated to the oral cancer are your responsibility.

 

Sample or Data Requirements

If you decide to participate in this study, your cat will receive palliative radiation therapy and one treatment with QR206. Your cat will undergo blood and urine tests/diagnostics prior to and during the course of treatment to record, baseline, mid treatment and post-treatment changes in health and tumor biopsies will also be taken.

Contact Info

For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at: clinicaltrials@tufts.edu

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