Clinical Trials

K9 Mammary Cancer Study

Through our collaboration with Vassar College, Department of Biology we are now evaluting:

HER2/ER Expression in K9 Mammary Cancer

Roughly 50% of K9 mammary cancers are benign but the other half have varible behaviors. In woman, the use of HER2/ER PCR and Immunohistochemistry is established, as part of a prognostic panel. We are now evaluating these markers with PCR based on a recent publication.

Virchows Arch. 2008 Aug;453(2):123-32. Epub 2008 Aug 2.

Identification of molecular phenotypes in canine mammary carcinomas with clinical implications: application of the human classification.

Gama A, Alves A, Schmitt F.

Department of Veterinary Sciences, CECAV, University of Trás-os-Montes and Alto Douro (UTAD), 5001-811, Vila Real, Portugal.

How you can contribute to our study:

When scheduling a biopsy of K9 mammary tissue, please call us at 845 632 3200. We will send you biopsy media to place a small sample for inclusion in the study. This is not a substitute for histopathology and there is no fee.

K9 Lymphoma Clinical Trial

The Veterinary Specialty Center of the Hudson Valley, Department of Oncology in collaboration with Vassar College announces our K9 Lymphoma Clinical Trial

We are currently enrolling K9 patients with B cell Lymphoma for a 9 week chemotherapy trial followed by vaccine.

(whole cell, anti-idiotype and CD20).

An entire peripheral lymph node will be harvested and vaccine created from the extirpated tissue from the individual patient

An abiding mystery in the understanding of cancer is why the cells are not destroyed by the immune system of the host. The predominant theory is that most cancers are in fact destroyed, but the rare tumor clone that survives has induced tolerance, mediated by regulatory T cells, in the host (called “sorting-out”). Thus, even a successful cancer has in fact induced an immune response, just not one of survival value to the host . Approaches designed to “break tolerance” and restore an anti-tumor response include: deleting T-suppressor/regulatory cells, hyper-stimulating the immune system with adjuvants, or interleukins, and custom designing tumor specific antigens to vaccinate with, including anti-id Ab for lymphoma , or CEA for colorectal , or Mart-1 for melanoma.

All of these approaches have had their problems; deleting T cells can induce auto-immune disease, hyperstimulation of the immune system has severe clinical side effects, and directing the vaccine to very specific tumor markers can allow the tumor to slide out from under the immune attack by simply down-regulating the expression of the target antigen.

There is, however, another approach to immune modulation which is now being reexamined: the cellular vaccine. The cellular vaccine has the advantage of expressing a wide variety of potential tumor targets to the host immune response, thus precluding tumor down regulation of specific markers, and it employs a mild adjuvant system which lowers side effects. By offering a wide variety of antigens and epitopes to the immune response, it offers the best chance of breaking tolerance and restoring anti-tumor immunity.

Instead of the traditional 25-27 week chemotherapy protocol for K9 B cell Lymphoma, this study will evaluate the efficacy of 9 weeks of chemotherapy with autogenous vaccine. Vaccine will be administered over 3 months if the patient has entered complete remission after 9 weeks of chemotherapy.

PCR for clonal identification of molecular remission will also be utilized from the lymph node and sequential serum sampling.

Lymphoma and Leukemia Clinical Trials

New Therapy for K9 Lymphoma and Leukemias

VSCHV is part of a clinical trial consortium that is evaluating nitrosylcobalamin (NO-Cbl) against K9 Lymphoma and Leukemias.

Nitrosylcobalamin promotes cell death via S nitrosylation of Apo2L/TRAIL receptor DR4. Tang Z, Bauer JA, Morrison B, Lindner DJ.
Mol Cell Biol. 2006 Aug;26(15):5588-94.

Nitric oxide attached to a vitamin B12 analog is a promising cytotoxic agent that targets tumor cells overexpressing B12 receptors. Long-term treatment with this chemotherapeutic agent -- nitrosylcobalamin (NO-Cbl) -- has so far resulted in up to 77% tumor volume reduction in three dogs that had spontaneous carcinoma, with no signs of toxicity. We call NO-Cbl a 'Trojan horse' because cancer cells require abnormally high levels of vitamin B12 to divide and proliferate. Cancer cells cannot distinguish NO-Cbl from regular B12, so NO-Cbl is readily ingested by the cancer cells and the nitric oxide is released and kills the cell from within by causing apoptosis."

The treated tumors in the dogs were a thyroid carcinoma, a malignant peripheral nerve sheath tumor, and an anal sac adenocarcinoma. After twice-daily injections of NO-Cbl for up to 15 months, tumor regression ranged from 43% to 77%, and an iliac lymph node metastasis was reduced by 90%.

Most cancers that respond well are adenocarcinomas, but the most sensitive to NO-Cbl are leukemias and lymphomas.

Before a dog is enrolled on the study it must have:

  • a CT scan or MR scan to measure the size of the tumor. The dog has to be put under general anesthesia for these scans
  • peripheral blood draw to obtain complete blood count and chemistry panel
  • a biopsy of the tumor or Flow Cytometry to confirm histology and diagnosis.

NO-Cbl is provided free of charge. We will teach the owner how to inject the NO-Cbl.sq. Blood tests must be repeated after 1 mo, 3 mo, 6 mo, and 12 mo. A repeat MR or CT scan must be obtained at 6 mo and at 12 mo to monitor the size of the tumor. If the tumor is not responding to NO-Cbl, dogs will be treated with NO-Cbl for one year. The dog owner is financially responsible for obtaining all blood work and scans.