Cummings School of Veterinary Medicine

Pilot assessment of BG34-200 in spontaneous canine cancers

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  • Recruiting
  • Dog
  • Oncology , Soft Tissue Surgery

Description

The purpose of this study is to evaluate the effectiveness of a new cancer immune therapy, BG34-200, for the treatment of canine cancer. BG34-200 is a new immune stimulant derived from oat bran that activates a specific set of immune cells called monocytes and macrophages. These cells are an important part of the tumor environment and can work to either stimulate or block the immune system’s ability to kill cancer cells. In mice, BG34-200 was able to shrink several different kinds of tumors. The current study will build on these findings to test how effective BG34-200 is in the setting of cancer in dogs.

Inclusion Criteria

  • Measurement of tumor burden (target and non-target lesion assessment)
  • Digital photo of tumor and other target lesions measurements if applicable
  • Pre-treatment tumor biopsy, draining lymph node aspirate, and bone marrow aspirate cytology
  • The following must be performed on Day 1 prior to drug administration:
  • Plasma, serum, and PBMC collection
  • Histologically or cytologically confirmed solid tumor malignancy; a minimum lesion size of 2 cm must be present in at least one site for sample collection and efficacy assessment.
  • Favorable performance status
  • Grade 0 or 1 (modified ECOG criteria); for dogs with concurrent primary site disease, adequate pain control must be in place prior to trial entry
  • Both newly diagnosed dogs and those with recurrent/relapsed disease are eligible
  • Informed owner consent (Approved by respective IACUC)
  • Non-steroidal anti-inflammatories are allowed if dogs receive for 7 days prior to study

Exclusion Criteria

  • Dogs < 15 kg
  • Dogs with lymphoma, mast cell tumors, or hemangiosarcoma
  • Dogs with distant metastasis (i.e. pulmonary, visceral, or other)
  • Metastatic osteosarcoma patients can be enrolled at the discretion of Dr. Flesner
  • No concurrent chemotherapy, immunotherapy, or radiation therapy
  • Dogs must be off of all such therapy for 2 weeks prior to study
  • Significant co-morbid illness, which includes but is not limited to renal or hepatic failure, history of congestive heart failure or clinical coagulopathy
  • creatinine > 3.0
  • bilirubin > 2.0 or elevated bile acids
  • HCT < 25%, platelets < 50,000
  • any > grade 2 hematologic/biochemical abnormality
  • uncontrolled pain and/or infection at the site of primary tumor

Client Benefits

The study will cover all costs associated with the study including screening and BG34-200 administration, as well as any costs associated with side effects from study related procedures. The study will not cover any costs due to unrelated conditions (ear infection, bladder infection, etc.). At the end of the study, you will receive a $1,000 credit at the Foster Hospital for Small Animals for additional care for your dog’s cancer.

Sample of Data Requirements

Your dog will need to have a diagnosis of cancer based on either a biopsy or a needle aspiration of the tumor. Bloodwork and chest x-rays and/or abdominal ultrasound will also need to be performed to check for evidence of tumor spread (metastasis) and to make sure that the liver, kidneys and other body systems are functioning normally. If your dog is enrolled in the study, he/she will be sedated and undergo a baseline tumor biopsy, collection of a blood sample (30 ml, approximately 2 tablespoons), a bone marrow collection and if possible a needle aspiration of a lymph gland close to the tumor. Your dog will then receive 4 weekly intravenous infusions of BG34-200; blood samples will also be collected at each study visit. After the first infusion, your dog will stay overnight in the hospital so we can collect additional blood samples that will help us understand how long BG34-200 stays in the bloodstream. One week after the last BG34-200 infusion, your dog will undergo a final blood collection, bone marrow collection and lymph gland needle aspiration, along with chest x-rays and/or abdominal ultrasound (if indicated). If your dog’s cancer has responded to treatment, you will have the option of continuing the BG34-200 treatment on a compassionate use basis.

Referring Physician Questionnaire

If you believe you have a patient who is eligible for this clinical trial study or you would like additional information from the Clinical Trials Office at the Cummings Veterinary Medical Center, complete a referring physician questionnaire.

Contact

For questions regarding the clinical trial please email clinicaltrials@tufts.edu.