| PET CANCER CENTER Comprehensive guide to cancer diagnosis and treatment in cats and dogs |
© 2007 Pet Cancer Center. ALL RIGHTS RESERVED.
Last updated 2/19/2017
Please take our short survey to help us understand pet owners' perception of clinical trials.
| Clinical trials for soft tissue sarcoma in dogs |
| Open clinical trials for dogs |
Find clinical trials for specific tumor types in dogs:
COLORADO
Study #1: Oncolytic Poxvirus Therapy for Soft Tissue Sarcoma in Dogs Pilot Safety Study.
Location: University of Wisconsin Veterinary Teaching Hospital, Madison, WI
Study Contact: Kara Hall at csuoncologytrials@colostate.edu or 970-297-4001
www.csuanimalcancercenter.org/oncolytic-poxvirus-therapy-for-soft-tissue-sarcoma-in-dogs-pilot-safety-study
Purpose of the study:
To determine if recombinant myxoma virus therapy is safe in dogs with soft tissue sarcoma. There are several ongoing
clinical trials testing the efficacy of oncolytic virotherapy in humans, but trials in canine cancer patients are extremely rare.
Mouse models of canine cancers have been successfully treated with oncolytic viruses. Clinical trials using oncolytic
virotherapy in dogs are the next step in the process of advancing treatment options for dogs with cancer.
Eligibility Criteria:
Dogs with a histologically confirmed diagnosis of soft tissue sarcoma. Biopsy tissue must be available for analysis. Tumor
must be at least 2 cm in diameter and accessible for biopsies. Prior surgery acceptable; 2 week washout from
chemotherapy, 6 weeks from radiation therapy. Dogs living in household with an immunocompromised person or a rabbit
will be ineligible.
Study Protocol:
Dogs will receive an injection of the poxvirus directly into the tumor Recheck visits are required 1, 4, 7, 14, & 28 days
following virus injection for collection of blood, urine, feces, and saliva to monitor for adverse effects and virus shedding.
Tumor biopsies will be performed on days 4 and 14 following virus injection. Study is completed at day 28 visit or earlier if
there is evidence of tumor progression or significant adverse effects of virus injection. The first three dogs enrolled in this
study will need to be hospitalized at CSU for 7 days following the virus injection.
Owner Responsibilities:
Cost of biopsy prior to starting treatment to confirm diagnosis. Follow appointment schedule required by study protocol.
Complete owner diary daily including documentation of tumor size, weight of dog, and any side effects noted
Financial Incentive:
Study pays for all costs associated with trial. VTH credit given at completion of trial to be used towards additional treatment
of $750.
Study #2: Post-operative Administration of Myxoma Virus to Reduce Recurrence of Soft Tissue
Sarcomas in Dogs – A Pilot Study.
Location: Colorado State University-Fort Collins, Colorado
Study Contact: Kara Hall at csuoncologytrials@colostate.edu or 970-297-4001
www.csuanimalcancercenter.org/post-operative-administration-of-myxoma-virus-to-reduce-recurrence-of-soft-tissue-
sarcomas-in-dogs-a-pilot-study
Purpose of the study:
Oncolytic poxvirus therapy will reduce the rate of sarcoma recurrence. The goal is to evaluate the immune response to
post-operative myxoma virus injection in dogs with soft tissue sarcomas
Eligibility Criteria:
Biopsy-confirmed grade II or III soft tissue sarcoma that is not amenable to complete surgical resection. Dogs must be
overall healthy with adequate blood work results
Study Protocol:
Pre-enrollment: Physical exam, labwork (blood tests, urinalysis), chest xrays, and biopsy if not already performed
Surgical excision of the tumor, with virus injection at the surgical site. Week 2: Recheck exam, labwork, and 2nd virus
injection at surgery site. Rechecks at 4, 6, 8, and 12 weeks, and ongoing every 2 months for 12 months
Owner Responsibilities:
Costs of initial testing to determine eligibility (labwork, chest x-rays, and pre-treatment biopsy, as well as any other tests
recommended by your pet's oncologist)
Financial Incentives:
Costs related to the surgery (anesthesia, histopathology, hospitalization, post-operative care, wound management), clinical
trial appointments, physical examinations, recommended follow-up chest x-rays, blood work, urinalysis, and immunological
studies will be covered by this study.
MISSOURI
Study: Use of CT/18F-FDG PET Imaging in the prognosis and pathologic evaluation of soft tissue
sarcoma.
Location: Veterinary Health Center University of Missouri
Study Contact: Debbie Tate, RVT, VTS (clinical trials coordinator) or the Oncology Clinical Trials Service at 573-882-7821
Recruitment End Date: 11/01/2017
http://vhc.missouri.edu/small-animal-hospital/oncology/clinical-trials/current-clinical-trials/
Rationale:
The goal of this trial is to evaluate the ability of 18F-FDG-PET to assist surgeons with tumor resection and pathologists
identify active tumor populations. Active tumor sections identified by the scan will be compared to standard slices of the
tumor by the pathologist and determined if the scan guidance improves the ability to identify aggressive tumors.
Purpose:
The goal of this project is to determine the biologic behavior of soft tissue sarcomas on PET and correlate it with a more
traditional histological grading system. This will be accomplished by using a well-established methodology which utilizes
18F-FDG-PET. Although limited studies have been performed in this regard with some encouraging results, there is a
need for further clarification of this technology in assessing patients with sarcomas beyond the initial diagnosis. While
structural imaging such as CT and MRI reveal the presence of sarcoma, they fail to characterize the current and future
biologic behavior of the tumor. Although the latter technologies have become very import in the surgical management of
patients, they have played a limited role in characterizing the biologic nature of the variable and complex cancer. Based on
prior date, information gained form molecular characterization of cancers by 18F-FDG-PET has aided in the management
of cancer patients. A need exists for prospective studies designed to answer critical question that will define the role of this
powerful modality in the management of patients with sarcoma. Our aim is to demonstrate that 18F-FDG-PET imaging
provides accurate information about this malignancy by correlating SUV-(standard uptake valve) 18F-FDG-PET with the
pathologic grading system of patient with sarcoma as well as determine if SUV changes within a tumor correlate to
differences amongst the aggressiveness of tumor cells, thereby enabling a biopsy directed towards the most viable and
aggressive tumor cells. A correlation between SUV and prognosis, disease free progression and overall survival will also
be evaluated.
Exclusions: Recurrent sarcoma, prior chemotherapy or radiation therapy to tumor site, tumor < 10 mm.
Expected Duration: Approximately one week.
Description of Procedures:
All patients enrolled will undergo staging procedures which will include a physical examination, Complete blood count
(CBC), chemistry profile, urinalysis, and thoracic radiographs. Prior to surgery patient will be anesthetized for CT scanning,
followed by an 18F-FDG-PET scan. Patients will be placed in the University of Missouri-Columbia Veterinary Health Center
(UMC-VHC) radiation isolation ward for 24 hours, at which time they will be released without further restriction. Patient will
be available for planned clinical surgery here at the UMC-VHC following release from radiation isolation. Following
resection, tumor regions will be compared to the PET scan data. No other interventions will be part of this clinical trial for
the participating dogs.
Financial Incentive:
Partially funded (owner cost >$1000).
OREGON
Study: Lomustine versus alternating lomustine and doxorubicin with zoledronic acid (Zoledronate) for
the first-line treatment of canine histiocytic sarcoma: a prospective, randomized, phase III trial
Location: Oregon State University-Corvallis, Oregon
Study Contact: Kaitlin Curran at katie.curran@oregonstate.edu or 1-541-737-4812
http://vetmed.oregonstate.edu/clinical-trials
Purpose:
This study will compare response and outcome data for dogs with histiocytic sarcoma treated with either single-agent
lomustine or alternating lomustine and doxorubicin combined with Zoledronate.
Eligibility:
Dogs with confirmed histiocytic sarcoma (localized, disseminated or hemophagocytic) based on cytology with
immunocytochemistry (ICC) or histopathology with immunohistochemistry (IHC) using CD18, CD3, CD79α or PAX5. Dogs
must be otherwise healthy, have adequate bone marrow and organ function, and weight > 5.0 kg. No previous medical
therapy will be allowed including concurrent prednisone administration. For those dogs currently receiving prednisone
therapy a 2 week wash-out period will be required prior to enrollment. Medications for pain management (including
NSAIDs) are allowed. Owners must sign consent form. Dogs must undergo full post-mortem examination (necropsy) if they
die while on study.
Exclusion criteria:
Dogs <5.0kg. Dogs who have received single-agent lomustine, or other previous medical therapy for histiocytic sarcoma.
Significant co-morbid illness, which includes but is not limited to renal or hepatic failure, history of congestive heart failure
or clinical coagulopathy. Creatinine > 3.0mg/dL. Bilirubin > 2.0mg/dL or elevated bile acids. ALT >300 U/L. Dogs on
homeopathic/alternative therapies are excluded. Exceptions include chondroitin sulphate, vitamins, essential fatty acids,
glucosamine and liver protectants (SAMe, Milk Thistle)
Financial Incentive:
Partially funded (owner cost >$1000)
VIRGINIA / MARYLAND
Study: Genetic Analysis of Disseminated Histiocytic Sarcoma.
Location: Virginia-Maryland College of Veterinary Medicine
Study Contact: Mindy Quigley at vettrials@vt.edu or 1-540-2311363
www.vetmed.vt.edu/clinical-trials/current-studies/histiocytic-sarcoma.asp
Purpose:
To determine the genetic basis of the disseminated form of Histiocytic Sarcoma (HS) and ultimately identify potential
targets for treating the disease.
Background:
The disseminated form of Histiocytic Sarcoma is often aggressive, deadly, and resistant to standard drug therapies. Some
breeds, such as Bernese Mountain Dogs, have an unusually high incidence of this rare form of cancer. Preliminary data
indicate that specific gene expression patterns are associated with the disseminated disease, suggesting the existence of
subtype-specific genetic alterations. We seek to identify the full complement of the most important genetic mutations in
disseminated HS, and determine their incidence in dogs with genetic predisposition to the disease.
Eligibility:
Dogs, especially Bernese Mountain Dogs, diagnosed or strongly suspected to have Histiocytic Sarcoma.
Exclusion Criteria:
Due to the sensitivity of our analysis, unfortunately we are unable to accept biopsy tissue obtained in other clinics and
fixed in formalin.
Study Design:
Dogs will undergo a simple biopsy to remove a small amount of tumor tissue. Genetic analysis will be undertaken to
determine tumor type.
Compensation:
The study will pay for the cost of a simple biopsy, laboratory analysis of this tissue, and, if elected, the cost for 1 dose of
CCNU chemotherapy, which is the current treatment standard for HS. As part of the Oncology Appointment, our cancer
specialists will also provide a full consultation regarding further diagnostics, treatment options, and prognosis. Costs not
covered by the study include the Consultation appointment, and any further diagnostics and treatments elected. No
experimental procedures or treatments will be involved.
Study #1: Oncolytic Poxvirus Therapy for Soft Tissue Sarcoma in Dogs Pilot Safety Study.
Location: University of Wisconsin Veterinary Teaching Hospital, Madison, WI
Study Contact: Kara Hall at csuoncologytrials@colostate.edu or 970-297-4001
www.csuanimalcancercenter.org/oncolytic-poxvirus-therapy-for-soft-tissue-sarcoma-in-dogs-pilot-safety-study
Purpose of the study:
To determine if recombinant myxoma virus therapy is safe in dogs with soft tissue sarcoma. There are several ongoing
clinical trials testing the efficacy of oncolytic virotherapy in humans, but trials in canine cancer patients are extremely rare.
Mouse models of canine cancers have been successfully treated with oncolytic viruses. Clinical trials using oncolytic
virotherapy in dogs are the next step in the process of advancing treatment options for dogs with cancer.
Eligibility Criteria:
Dogs with a histologically confirmed diagnosis of soft tissue sarcoma. Biopsy tissue must be available for analysis. Tumor
must be at least 2 cm in diameter and accessible for biopsies. Prior surgery acceptable; 2 week washout from
chemotherapy, 6 weeks from radiation therapy. Dogs living in household with an immunocompromised person or a rabbit
will be ineligible.
Study Protocol:
Dogs will receive an injection of the poxvirus directly into the tumor Recheck visits are required 1, 4, 7, 14, & 28 days
following virus injection for collection of blood, urine, feces, and saliva to monitor for adverse effects and virus shedding.
Tumor biopsies will be performed on days 4 and 14 following virus injection. Study is completed at day 28 visit or earlier if
there is evidence of tumor progression or significant adverse effects of virus injection. The first three dogs enrolled in this
study will need to be hospitalized at CSU for 7 days following the virus injection.
Owner Responsibilities:
Cost of biopsy prior to starting treatment to confirm diagnosis. Follow appointment schedule required by study protocol.
Complete owner diary daily including documentation of tumor size, weight of dog, and any side effects noted
Financial Incentive:
Study pays for all costs associated with trial. VTH credit given at completion of trial to be used towards additional treatment
of $750.
Study #2: Post-operative Administration of Myxoma Virus to Reduce Recurrence of Soft Tissue
Sarcomas in Dogs – A Pilot Study.
Location: Colorado State University-Fort Collins, Colorado
Study Contact: Kara Hall at csuoncologytrials@colostate.edu or 970-297-4001
www.csuanimalcancercenter.org/post-operative-administration-of-myxoma-virus-to-reduce-recurrence-of-soft-tissue-
sarcomas-in-dogs-a-pilot-study
Purpose of the study:
Oncolytic poxvirus therapy will reduce the rate of sarcoma recurrence. The goal is to evaluate the immune response to
post-operative myxoma virus injection in dogs with soft tissue sarcomas
Eligibility Criteria:
Biopsy-confirmed grade II or III soft tissue sarcoma that is not amenable to complete surgical resection. Dogs must be
overall healthy with adequate blood work results
Study Protocol:
Pre-enrollment: Physical exam, labwork (blood tests, urinalysis), chest xrays, and biopsy if not already performed
Surgical excision of the tumor, with virus injection at the surgical site. Week 2: Recheck exam, labwork, and 2nd virus
injection at surgery site. Rechecks at 4, 6, 8, and 12 weeks, and ongoing every 2 months for 12 months
Owner Responsibilities:
Costs of initial testing to determine eligibility (labwork, chest x-rays, and pre-treatment biopsy, as well as any other tests
recommended by your pet's oncologist)
Financial Incentives:
Costs related to the surgery (anesthesia, histopathology, hospitalization, post-operative care, wound management), clinical
trial appointments, physical examinations, recommended follow-up chest x-rays, blood work, urinalysis, and immunological
studies will be covered by this study.
MISSOURI
Study: Use of CT/18F-FDG PET Imaging in the prognosis and pathologic evaluation of soft tissue
sarcoma.
Location: Veterinary Health Center University of Missouri
Study Contact: Debbie Tate, RVT, VTS (clinical trials coordinator) or the Oncology Clinical Trials Service at 573-882-7821
Recruitment End Date: 11/01/2017
http://vhc.missouri.edu/small-animal-hospital/oncology/clinical-trials/current-clinical-trials/
Rationale:
The goal of this trial is to evaluate the ability of 18F-FDG-PET to assist surgeons with tumor resection and pathologists
identify active tumor populations. Active tumor sections identified by the scan will be compared to standard slices of the
tumor by the pathologist and determined if the scan guidance improves the ability to identify aggressive tumors.
Purpose:
The goal of this project is to determine the biologic behavior of soft tissue sarcomas on PET and correlate it with a more
traditional histological grading system. This will be accomplished by using a well-established methodology which utilizes
18F-FDG-PET. Although limited studies have been performed in this regard with some encouraging results, there is a
need for further clarification of this technology in assessing patients with sarcomas beyond the initial diagnosis. While
structural imaging such as CT and MRI reveal the presence of sarcoma, they fail to characterize the current and future
biologic behavior of the tumor. Although the latter technologies have become very import in the surgical management of
patients, they have played a limited role in characterizing the biologic nature of the variable and complex cancer. Based on
prior date, information gained form molecular characterization of cancers by 18F-FDG-PET has aided in the management
of cancer patients. A need exists for prospective studies designed to answer critical question that will define the role of this
powerful modality in the management of patients with sarcoma. Our aim is to demonstrate that 18F-FDG-PET imaging
provides accurate information about this malignancy by correlating SUV-(standard uptake valve) 18F-FDG-PET with the
pathologic grading system of patient with sarcoma as well as determine if SUV changes within a tumor correlate to
differences amongst the aggressiveness of tumor cells, thereby enabling a biopsy directed towards the most viable and
aggressive tumor cells. A correlation between SUV and prognosis, disease free progression and overall survival will also
be evaluated.
Exclusions: Recurrent sarcoma, prior chemotherapy or radiation therapy to tumor site, tumor < 10 mm.
Expected Duration: Approximately one week.
Description of Procedures:
All patients enrolled will undergo staging procedures which will include a physical examination, Complete blood count
(CBC), chemistry profile, urinalysis, and thoracic radiographs. Prior to surgery patient will be anesthetized for CT scanning,
followed by an 18F-FDG-PET scan. Patients will be placed in the University of Missouri-Columbia Veterinary Health Center
(UMC-VHC) radiation isolation ward for 24 hours, at which time they will be released without further restriction. Patient will
be available for planned clinical surgery here at the UMC-VHC following release from radiation isolation. Following
resection, tumor regions will be compared to the PET scan data. No other interventions will be part of this clinical trial for
the participating dogs.
Financial Incentive:
Partially funded (owner cost >$1000).
OREGON
Study: Lomustine versus alternating lomustine and doxorubicin with zoledronic acid (Zoledronate) for
the first-line treatment of canine histiocytic sarcoma: a prospective, randomized, phase III trial
Location: Oregon State University-Corvallis, Oregon
Study Contact: Kaitlin Curran at katie.curran@oregonstate.edu or 1-541-737-4812
http://vetmed.oregonstate.edu/clinical-trials
Purpose:
This study will compare response and outcome data for dogs with histiocytic sarcoma treated with either single-agent
lomustine or alternating lomustine and doxorubicin combined with Zoledronate.
Eligibility:
Dogs with confirmed histiocytic sarcoma (localized, disseminated or hemophagocytic) based on cytology with
immunocytochemistry (ICC) or histopathology with immunohistochemistry (IHC) using CD18, CD3, CD79α or PAX5. Dogs
must be otherwise healthy, have adequate bone marrow and organ function, and weight > 5.0 kg. No previous medical
therapy will be allowed including concurrent prednisone administration. For those dogs currently receiving prednisone
therapy a 2 week wash-out period will be required prior to enrollment. Medications for pain management (including
NSAIDs) are allowed. Owners must sign consent form. Dogs must undergo full post-mortem examination (necropsy) if they
die while on study.
Exclusion criteria:
Dogs <5.0kg. Dogs who have received single-agent lomustine, or other previous medical therapy for histiocytic sarcoma.
Significant co-morbid illness, which includes but is not limited to renal or hepatic failure, history of congestive heart failure
or clinical coagulopathy. Creatinine > 3.0mg/dL. Bilirubin > 2.0mg/dL or elevated bile acids. ALT >300 U/L. Dogs on
homeopathic/alternative therapies are excluded. Exceptions include chondroitin sulphate, vitamins, essential fatty acids,
glucosamine and liver protectants (SAMe, Milk Thistle)
Financial Incentive:
Partially funded (owner cost >$1000)
VIRGINIA / MARYLAND
Study: Genetic Analysis of Disseminated Histiocytic Sarcoma.
Location: Virginia-Maryland College of Veterinary Medicine
Study Contact: Mindy Quigley at vettrials@vt.edu or 1-540-2311363
www.vetmed.vt.edu/clinical-trials/current-studies/histiocytic-sarcoma.asp
Purpose:
To determine the genetic basis of the disseminated form of Histiocytic Sarcoma (HS) and ultimately identify potential
targets for treating the disease.
Background:
The disseminated form of Histiocytic Sarcoma is often aggressive, deadly, and resistant to standard drug therapies. Some
breeds, such as Bernese Mountain Dogs, have an unusually high incidence of this rare form of cancer. Preliminary data
indicate that specific gene expression patterns are associated with the disseminated disease, suggesting the existence of
subtype-specific genetic alterations. We seek to identify the full complement of the most important genetic mutations in
disseminated HS, and determine their incidence in dogs with genetic predisposition to the disease.
Eligibility:
Dogs, especially Bernese Mountain Dogs, diagnosed or strongly suspected to have Histiocytic Sarcoma.
Exclusion Criteria:
Due to the sensitivity of our analysis, unfortunately we are unable to accept biopsy tissue obtained in other clinics and
fixed in formalin.
Study Design:
Dogs will undergo a simple biopsy to remove a small amount of tumor tissue. Genetic analysis will be undertaken to
determine tumor type.
Compensation:
The study will pay for the cost of a simple biopsy, laboratory analysis of this tissue, and, if elected, the cost for 1 dose of
CCNU chemotherapy, which is the current treatment standard for HS. As part of the Oncology Appointment, our cancer
specialists will also provide a full consultation regarding further diagnostics, treatment options, and prognosis. Costs not
covered by the study include the Consultation appointment, and any further diagnostics and treatments elected. No
experimental procedures or treatments will be involved.