Trial Summary


Approximately thirty client-owned dogs will be enrolled in this exploratory study. All dogs will receive the novel therapeutic treatment (no placebo).

Trial Funding


This study is funded. The compound is provided at no cost and all study visit fees, blood tests, urine tests, and other diagnostic tests specified in the protocol are paid for by the study. The management of side effects considered directly associated with the study compound are paid for by the sponsor. All other costs, including but not limited to transportation and veterinary care that is not associated with the study, are the responsibility of the dog owner.

Trial Eligibility

Inclusion criteria for participation in this clinical trial includes:

• Dog must be > 1 year of age.
• Dog has first relapse lymphoma with cytological or histological diagnosis of either T or B cell type lymphoma.
• Evidence of disease progression on study entry is based on direct tumor measurement.
• At least one peripherally located lymph node measures ≥ 2 cm longest diameter.
• Dog must demonstrate adequate organ function as indicated by CBC, chemistry, and urinalysis,
• Dog must have received no or only one prior systemic chemotherapy treatment regimen (single agent or multi-agent).
• Dog must have completed any prior chemotherapy at least 14 days prior to study entry.
• Dog must have recovered from any acute toxicities of prior chemotherapy treatment.
• Dog must have a Performance Score of 0 or 1 [0 = normal activity; 1 = restricted activity: decreased activity from pre-disease status].
• Life expectancy of ≥ 1 month.
• Owner must be able to administer drug according to designated schedule.

Exclusion criteria for participation in this study includes:

• Dog weighs < 5 kg.
• Dog has received radiation therapy.
• Dog has evidence of lymphoma involving the CNS.
• Dog has significant bulky disease such that clinical deterioration is likely to occur even in the setting of stable disease.
• Dog has any serious medical condition (renal, cardiovascular, hepatic, concurrent malignancy) that may preclude successful treatment outcome.
• Dog shows evidence of diabetes mellitus or other on-going serious endocrine disorder.
• Dog has serum calcium ≥ 13.0 mg/dL.
• Dog is participating in another study or has received investigational therapy in the past 7 days.
• Dog is currently using complementary or alternative medicines that in the opinion of the investigator would confound the interpretation of toxicities and/or antitumor activity of the investigational product.
• Dog is pregnant or likely to become pregnant.
• Dog may be unavailable for the entire study duration or is felt to be unsuitable by the investigator for any other reason.

Trial Participation

The following animal hospitals are offering this clinical trial:

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Trial Summary

It is anticipated that 36 client-owned pet dogs will be enrolled in this placebo-controlled study in dogs with measurable peripheral node lymphoma. The randomization of Investigational Product to placebo will be 1:1.

Study patients will receive the Investigational Product or placebo at Day 0 and Day 7 of this 21-day study.

Trial Support and Funding

This study provides funding during the study period for all study-related costs including the screening, study visit evaluations while on study, and all necessary diagnostics, treatment and management of adverse events that are possibly attributed to therapy. Additionally, $2000 will be paid towards oncology care after the trial for each dog enrolled in the study.

Trial Eligibility

Inclusion criteria:

• Written owner informed consent has been obtained prior to screening the dog
• Client-owned dog > 1 yr of age with body weight > 1.7 kg
• Cytological or histological diagnosis of lymphoma stage IIIa-Va
• At least one peripherally located lymph node measuring > 2 cm longest diameter (LD)
• Naïve or relapsed T-cell or B-cell lymphoma
• Adequate organ function as determined by the investigator
• Life expectancy of > 1 month
• Performance Score of 0 or 1 [0 = normal activity; 1 = restricted activity: decreased activity from pre-disease status]

Exclusion criteria:

• Glucocorticoid therapy within 2 weeks of enrollment
• Chemotherapy within 3 weeks of enrollment
• Prior immunotherapy
• Evidence of diabetes mellitus or on-going gastrointestinal disorder
• Any serious medical condition (including other concurrent malignancy) that may be disruptive to the intent and objectives of the study
• Dog is pregnant or likely to become pregnant
• Dog is participating in another study
• Dog may be unavailable for the entire study duration
• Dog has bulky disease, as interpreted by the investigator, and is considered at risk for tumor lysis syndrome

Trial Locations

The following veterinary oncology specialty practice is offering this clinical trial:

The Veterinary Cancer Center
129 Glover Ave
Norwalk, CT 06850
P: (203) 838-6626
www.vcchope.com

The post Funded Clinical Trial for Dogs with Lymphoma appeared first on Animal Clinical Investigation, LLC.

Trial Summary
A maximum of 30 client-owned dogs will be enrolled in this open-label study. All dogs will receive the novel therapeutic treatment (no placebo). Enrolled patients will have the opportunity to receive a minimum of 3 cycles of treatment with a cycle being 6 treatments.

Trial Funding
The study compound is provided at no cost. There is no other financial compensation. All visit fees, blood test, urine tests, or other diagnostic tests recommended by the veterinarian are the financial responsibility of the owner. In addition, the management of side effects considered directly or indirectly associated with the study compound are the responsibility of the owner.

Trial Eligibility

Inclusion criteria for participation in this clinical trial includes:

• Owner consent prior to enrollment in the study
• Any breed, sex or age, weighing > 5kg with measureable cancer
• A histological or cytological diagnosis of cancer has been obtained
• Dogs that have failed standard therapy or owner has declined standard therapy
• Dogs that have at least 1 palpable lesion measuring > 1cm diameter
• Dogs that have a favorable Performance Score 0-1 (based on modified Eastern Cooperative Oncology Group Performance Score)

Exclusion criteria for participation in this clinical trial includes:

• Anticipated poor owner compliance
• Dogs that have received anti-cancer therapy of any type (e.g. chemotherapy, radiation therapy, immunotherapy) within 3 weeks prior to study treatment start
• Dogs that have a concurrent medical disorder likely to result in death or euthanasia within 1 month or a condition that may be disruptive to the intent and objectives of the study
• Dogs that are pregnant or likely to become pregnant
• Dogs that are participating in another study
• Dogs that may be unavailable for the full duration of the trail or that is felt to be unsuitable by the investigator for any other reason

Trial Participation

The following animal hospitals are offering this clinical trial:

The post Novel treatment for Dogs with Measurable Cancer appeared first on Animal Clinical Investigation, LLC.