Evaluation of a novel immunomodulator composed of human chorionic gonadotropin and bacillus Calmette-Guerin for treatment of canine mast cell tumors in clinically affected dogs

Carolyn J. Henry Department of Veterinary Medicine and Surgery, College of Veterinary Medicine, University of Missouri-Columbia, Columbia, MO 65211

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Sue Downing Veterinary Cancer Referral Group, 1044 S Robertson Blvd, Los Angeles, CA 90035

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Robert C. Rosenthal Veterinary Specialists of Rochester, 825 White Spruce Blvd, Rochester, NY 14623

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Mary Kay Klein Southwest Veterinary Specialty Center, 141 E Fort Lowell Rd, Tucson, AZ 85705

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Karri Meleo Veterinary Oncology Services, 22226 Hwy 99, Edmonds, WA 98026

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J. Armando Villamil Department of Veterinary Medicine and Surgery, College of Veterinary Medicine, University of Missouri-Columbia, Columbia, MO 65211

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Linda S. Fineman Pacific Veterinary Specialists, 1980 41st Ave, Capitola, CA 95010

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Dudley L. McCaw Department of Veterinary Medicine and Surgery, College of Veterinary Medicine, University of Missouri-Columbia, Columbia, MO 65211

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Mary Lynn Higginbotham Department of Veterinary Medicine and Surgery, College of Veterinary Medicine, University of Missouri-Columbia, Columbia, MO 65211

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John McMichael Milkhaus Laboratories, 70 Elm St, Providence, RI 02903

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Abstract

Objective—To evaluate safety and efficacy of LDI-100, a preparation containing human chorionic gonadotropin (hCG) and bacillus Calmette-Guerin (BCG), in the treatment of dogs with mast cell tumors and to compare results with those from a control group receiving single-agent vinblastine.

Animals—95 dogs with measurable grade II or III mast cell tumors.

Procedures—Dogs were randomized to receive either LDI-100 (1.35 ng of BCG and 2 units of hCG, SC, q 24 h) or vinblastine (2 mg/m2, IV, q 1 wk) for 6 weeks. Tumors were measured at baseline and day 42, and dogs were monitored for signs of toxicosis. Clinical performance scores were recorded at each visit. Differences in host factors (sex, weight, and age), clinical performance score, tumor response, and adverse events were analyzed.

Results—46 dogs received LDI-100, and 49 dogs received vinblastine. No significant differences were found between the 2 treatment groups with regard to host factors or clinical performance score. Tumor response (≥50% reduction) rates were similar between the LDI-100 and vinblastine group (28.6% and 11.7%, respectively). Dogs in the LDI-100 group had significantly less neutropenia than the vinblastine group.

Conclusions and Clinical Relevance—hCG and BCG have immunomodulatory and antitumor effects against a variety of malignancies in humans and dogs. In this study, LDI-100 provided clinical responses comparable to single-agent vinblastine chemotherapy but without myelosuppression. LDI-100 is a promising new agent that should be further investigated for multimodality therapy of mast cell tumors in dogs.

Abstract

Objective—To evaluate safety and efficacy of LDI-100, a preparation containing human chorionic gonadotropin (hCG) and bacillus Calmette-Guerin (BCG), in the treatment of dogs with mast cell tumors and to compare results with those from a control group receiving single-agent vinblastine.

Animals—95 dogs with measurable grade II or III mast cell tumors.

Procedures—Dogs were randomized to receive either LDI-100 (1.35 ng of BCG and 2 units of hCG, SC, q 24 h) or vinblastine (2 mg/m2, IV, q 1 wk) for 6 weeks. Tumors were measured at baseline and day 42, and dogs were monitored for signs of toxicosis. Clinical performance scores were recorded at each visit. Differences in host factors (sex, weight, and age), clinical performance score, tumor response, and adverse events were analyzed.

Results—46 dogs received LDI-100, and 49 dogs received vinblastine. No significant differences were found between the 2 treatment groups with regard to host factors or clinical performance score. Tumor response (≥50% reduction) rates were similar between the LDI-100 and vinblastine group (28.6% and 11.7%, respectively). Dogs in the LDI-100 group had significantly less neutropenia than the vinblastine group.

Conclusions and Clinical Relevance—hCG and BCG have immunomodulatory and antitumor effects against a variety of malignancies in humans and dogs. In this study, LDI-100 provided clinical responses comparable to single-agent vinblastine chemotherapy but without myelosuppression. LDI-100 is a promising new agent that should be further investigated for multimodality therapy of mast cell tumors in dogs.

Contributor Notes

Dr. Downing's present address is City of Angels Veterinary Specialty, 9599 Jefferson Blvd, Culver City, CA 90232.

Dr. Rosenthal's present address is SouthPaws Veterinary Specialists & Emergency Center, 8500 Arlington Blvd, Fairfax, VA 22031.

Dr. McCaw and Dr. Higginbotham's present address is Department of Clinical Sciences, College of Veterinary Medicine, Kansas State University, Manhattan, KS 66506-5701.

Supported by Milkhaus Laboratories Incorporated.

Presented in part at the 23rd Annual Conference of the Veterinary Cancer Society, Pine Mountain, Ga, October 2006.

The authors thank Dr. Lynn Wheeler and John Fredericks for their assistance with study design and Drs. Michael Casler, Wesley Lee, and Nicole Northrup for providing dogs and follow-up information.

Address correspondence to Dr. Henry.
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