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Exploring new treatment option for Soft Tissue Sarcoma in Dogs

An Exploratory study of antibody-immune Protein (mab-IMP) in Dogs with Soft Tissue Sarcoma

Status: Suspended

Species: Dog

Veterinary Speciality: Oncology

Description

Antibody-Immune Protein (mAb-IMP) is a protein involved in stimulating the immune system. The expression of this protein is often low in tumors and is thought to be one of the reasons why the immune system does not do a better job at recognizing and killing tumor cells. The purpose of this clinical trial is to determine whether injecting mAb-IMP protein in dog sarcomas can induce a local immune response that results in the killing of tumor cells. A previous study performed using another version of the IMP protein showed some benefit to dogs with soft tissue sarcoma. The data generated from this follow-up study will provide new information regarding the potential effectiveness of mAb-IMP therapy and ultimately may lay the groundwork for larger clinical trials of this agent

 

Inclusion Criteria

  • Dogs diagnosed with cytologically or histologically confirmed spontaneous soft tissue sarcoma  (at least 2 cm but no larger than 10 cm in size) amenable to repeat biopsy are eligible for enrollment. The dog may have failed standard therapy (surgery, chemotherapy, radiation therapy), or there may be no other known effective therapeutic options, or the owner may elect to enter the dog in lieu of standard therapy.
  • Dogs must be at least 1 year of age and a minimum of 10 kg in body weight.
  • Adequate organ function as indicated by standard laboratory tests (complete blood count, serum biochemistry profile, urinalysis).
    • ANC≥1000/μL and platelet count ≥ 100,000/μL
    • Liver: Total bilirubin ≤ 1.5X the institutional upper limit of normal (ULN), ALT ≤ 3X ULN
    • ECOG performance score of 0-1
  • Otherwise medically healthy with no clinically significant physical findings upon examination, medical history, and clinical laboratory profile, as deemed by the Principal Investigators.
  • Dogs must have an estimated life expectancy of at least 28 days.
  • Prior chemotherapy or radiation must be completed 2 weeks prior to Study entry and the patient must have recovered from the acute toxicities of these treatments.
  • Participation is limited to those clients that can travel to Grafton, MA for all required visits.
  • Informed written consent must be obtained

Exclusion Criteria

  • Pregnant or lactating dogs
  • Evidence of brain metastasis
  • Concurrent use of complementary or alternative medicines that in the opinion of the Principal Investigator would confound the interpretation of toxicities and/or antitumor activity of the Study Drug.
  • Dogs with significant liver or cardiovascular disease.
  • Less than 2 weeks from a major surgical procedure.
  • Any serious systemic disorder incompatible with the Study (at the discretion of the Principal Investigator).
  • Use of any other investigational drug within 2 weeks of Study entry.

Client Benefits

The study will cover all diagnostics (bloodwork, x-rays, etc) and treatments (biopsies, mAb injections) associated with the sarcoma while your dog is enrolled in this study as well as the management of any study related side effects. Additionally, a $2,000 credit will be provided at the Foster Hospital for Small Animals for removal of the tumor and/or additional therapy (local radiation, etc.) after study completion. Except for the specific financial support described here, any tests or procedures unrelated to this study including treatment of conditions unrelated to the sarcoma are your responsibility.

 

Sample or Data Requirements

  Screening Day -14 to -7 Day 0 Day 7 Day 14 Day 21 Day 28
Physical Exam X X X X X X
Cytology Confirmation (if necessary) X
CBC X X X X X
Chemistry Panel X X X
Urinalysis (Dipstick) X X
Thoracic Radiographs X
Plasma Collection X X X X X X
PBMC Collection X X X X X X
Tumor Biopsy X X X X
mAb-IMP injection X X X  X
Tumor Assessment X X X X X
Quality of Life Assessment X X X X X
Surgical Removal of Tumor X*

*On day 28, if possible, the tumor will be removed surgically. If the tumor is too large for removal, but has remained stable or is now smaller, additional injections may be given depending on the availability of the product. Should this be the case, a final set of biopsies will be obtained prior to re-injection of the tumor. If your dog’s tumor measure’s larger at the end of the study then we will determine if your dog received the mAb (placebo) alone by unblinding the study and if so, your dog will be eligible to receive 4 injections of the mAb-IMP. Therefore, all dogs enrolled in this study will have an opportunity to receive the mAb-IMP.

 

Contact Info

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

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