National Cancer Institute - Cancer.gov

Closed Clinical Trials

All of the clinical studies listed below have been completed.

Purpose:

This clinical trial sponsored by the National Cancer Institute (NCI) evaluates the safety and effectiveness of the phage-based delivery of an agent known as Tumor Necrosis Factor (TNF alpha). TNF alpha is known to kill cancer cells and the blood vessels that feed them. It is currently used in human cancer patients as an isolated infusion and efforts to find new ways to deliver it safely have been underway for some time. The NCI has developed a special way to deliver TNF-alpha specifically to blood vessels around tumors using a molecular approach based on a viral-like carrier (phage). Results of this trial in dogs will be used to inform the design and implentation of planned clinical trails in human cancer patients.

Participating Sites:

Sponsor: The National Cancer Institute

Study Numbers:15-20 dogs will be enrolled in each study

Eligibility Requirements:

  • Hisotogically confirmed, Measurable disease (<2cm), can be primary and/or metastatic
  • Favorable performance status
  • Naïve or recurrent disease
  • Dogs must be more than 15kg
  • Dogs cannot receive concurrent chemotherapy, radiation or angiogenesis for 4 weeks prior to study enrollment.

Publication: Launching a Novel Preclinical Infrastructure: Comparative Oncology Trials Consortium Directed Therapeutic Targeting of TNFα to Cancer Vasculature, PLoS One

Purpose:

This clinical trial seeks to identify a safe, pharmacokinetically/pharmacodynamically relevant dose of Rapamycin in tumor bearings dogs. Currently, Rapamycin is approved as an immunosuppressive agent used in the setting of organ and bone marrow transplant. Results of this trial will directly inform the development efforts of Rapamycin analogues currently underway by providing the groundwork for follow-up studies that will assess optional Rapamycin dose and schedule.

Participating Sites:

Sponsor: Morris Animal Foundation and The National Cancer Institute

Study Numbers: 20-25 dogs will be enrolled

Eligibility Requirements:

  • Hitologically confirmed, osteosarcoma
  • Favorable performance status
  • Measurable disease that is amenable to serial biopsy
  • No concurrent chemotherapy or radiation therapy for 2 weeks prior to study enrollment.

Publication: Rapamycin pharmacokinetic and pharmacodynamic relationships in osteosarcoma: a comparative oncology study in dogs, PLoS One

Purpose:

A pre-clinical trial of immunocytokine in tumor bearing dogs is intended to define acute and chronic toxicities and activity of this immunotherapeutic agent in a spontaneous tumor model. The trial is divided into two steps: (1) Dose escalation & tolerability study --- in which we expect to gain insight into the optimal dose, and early indication of any anti-tumor activity and (2) Efficacy study with the best-chosen dose.

Participating Sites:

Sponsor: Pharmaceutical Company

Study Numbers: 10-15 dogs will be enrolled to the first phase of this study

Eligibility Requirements:

  • histologically confirmed lymphoma melanoma or soft tissue sarcoma Favorable performance status
  • both newly diagnosed dogs and those with recurrent disease are eligible
  • Dogs cannot receive concurrent chemotherapy, radiation or angiogenesis for 3 weeks prior to study enrollment
  • no current or of history of immune mediated disease (IMHA, ITP, SLE, etc).

Purpose:

The development of novel and targeted cancer drugs has required innovative clinical trial designs that seek to define drug (pharmacokinetic) and host (pharmacodynamic) relationships early in the development process. For most new cancer agents it will be helpful if these pharmacodynamic endpoints are measured in tumor tissue. Many targets for cancer agents are influenced by variables including body temperature, pH, vascular supply, and enzyme activity following removal of tissues from the patient. Accordingly, novel tissue collection procedures and instruments are needed to ensure that pharmacodynamic endpoint assessments are not altered from their actual in vivo "state" during the collection process. This study aims to evaluate a novel biopsy instrument and compare it to standard biopsy techniques (Tru-cut, resection) and assess a novel blood collection method to identify circulating tumor cells.

Participating Sites:

Sponsor: National Cancer Institute-Division of Cancer Treatment and Diagnosis

Study Numbers: 10-15 dogs anticipated

Eligibility Requirements:

  • Diagnosis of nodal lymphoma via standard assessments i.e. cytology (histology may be confirmed following biopsy if needed)
  • Measurable disease, naive (> 3 cm diameter) that is amenable to incisional biopsies of two distinct lymph nodes
  • Informed owner consent for planned open surgical biopsy and lymph node resection
  • Favorable performance status
  • No previous treatment with chemotherapy or steroids
  • No 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

Purpose:

Signaling through the mTOR pathway has been recently shown to contribute to the growth, progression and chemo resistance of several cancers. Accordingly, agents that act against this pathway, namely Rapamycin and its analogs (Rapalogs), have been developed as potentially valuable therapeutics for cancer, with a particular emphasis on sarcomas and osteosarcoma. However the use of mTOR inhibitors requires optimization of dose and regimen. This study seeks to define and compare three schedules for chronic delivery of Rapamycin using endpoints of tolerability, blood Rapamycin levels, modulation of mTOR targets in the blood and anti-tumor activity against pulmonary metastatic disease. Dogs will receive intramuscular injections at home on varying schedules (sometimes daily) and return weekly to their COTC site for evaluation and serial blood collections. Tumor burden will be assessed monthly.

Participating Sites:

Sponsor: Morris Animal Foundation and The Center for Cancer Research, NCI. Scientific endorsement from the Children's Oncology Group and the Sarcoma Alliance for Research through Cooperation (SARC)

Study Numbers: 24-30 dogs anticipated (8 per schedule arm)

Eligibility Requirements:

  • Radiographically measurable osteosarcoma pulmonary metastases (may be presumed based on clinical history)
  • Pulmonary metastatic burden < 15 metastatic lesions; no lesion greater than 5 cm diameter. Concurrent organ metastatic sites are permissible
  • Rapamycin as the sole therapy (NSAIDs allowed if on for 30 days)
  • Favorable performance status and life expectancy of at least 60 days
  • Informed owner consent
  • No 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

Purpose:

This clinical trial seeks to identify the bioavailablity of orally administered Rapamycin in tumor bearings dogs. Currently, Rapamycin is approved as an immunosuppressive agent used in the setting of organ and bone marrow transplant. Results of this trial will directly inform the development efforts of Rapamycin analogues currently underway by providing the groundwork for follow-up studies that will assess optional Rapamycin dose and schedule.

Participating Sites:

Sponsor: Morris Animal Foundation and The National Cancer Institute

Study Numbers: 15-20 dogs anticipated

Eligibility Requirements:

  • histologically confirmed malingancy
  • measurable disease that is amenable to evaluation
  • favorable performance status
  • both newly diagnosed dogs and those with recurrent disease are eligible
  • Informed owner consent
  • No 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

Purpose:

A pre-clinical trial of two immunocytokines in tumor bearing dogs is intended to define acute and chronic toxicities and activity of these immunotherapeutic agents in a spontaneous tumor model. The trial is divided into two steps: (1) Dose escalation & tolerability study --- in which we expect to gain insight into the optimal dose, and early indication of any anti-tumor activity and (2) Efficacy study with the best-chosen dose.

Participating Sites:

Sponsor: Pharmaceutical Company

Study Numbers: 20-25 dogs anticipated

Eligibility Requirements:

  • histologically confirmed melanoma
  • measurable disease that is accessible to serial peripheral measurements
  • tumor size that is greater than 2 cm and less than 8 cm in the longest dimension
  • favorable performance status
  • both newly diagnosed dogs and those with recurrent disease are eligible
  • No 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

Publication: Defining the Pharmacodynamic Profile and Therapeutic Index of NHS-IL12 Immunocytokine in Dogs with Malignant Melanoma, PLoS One

Purpose:

This clinical trial sponsored by the National Cancer Institute (NCI) assesses the safety and effectiveness of Topotecan when given to dogs with lymphoma. Topotecan is an approved chemoterapeutic used to treat several different cancers in human patients. It has yet to be evaluated in the treatment of canine cancers. Results of this trial will directly inform the development efforts of a novel therapy phase of several Topoisomerase I inhibitors candidates.

Participating Sites:

Sponsor: The National Cancer Institute

Study Numbers: 10-15 dogs anticipated

Eligibility Requirements:

  • histologically confirmed lymphoma
  • measurable disease that is amenable to biopsy
  • favorable performance status
  • both newly diagnosed dogs and those with recurrent/relapse disease are eligible
  • No 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

Purpose:

A pilot study in pet dogs with cancer is needed to determine the feasibility of tissue collection, clinical utility, and large-scale target interrogation across a multi-institutional setting. Data from this feasibility study will inform the design of a personalized therapeutic intent trial in pet dogs. Future comparative oncology modeling of novel personalized medicine strategies will hopefully progress the field and translate into more efficient targeted therapy prescriptions for human cancer patients.

Participating Sites:

Eligibility Requirements (one of the following):

  • Scottish terriers with transitional cell carcinoma of the bladder
  • Golden retrievers with multi-centric lymphoma
  • American cocker spaniels with oral melanoma
  • No 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

Publication: Prospective molecular profiling of canine cancers provides a clinically relevant comparative model for evaluating personalized medicine (PMed) trials, PLoS One

Purpose:

Pre-clinical trial of a novel anticancer agent in tumor bearing dogs with either melanoma, soft tissue sarcoma, squamous cell carcinoma or mammary carcinom is intended to define biological changes in tumor and surrogate tissues following drug exposure that may elucidate mechanisms of action and potential biomarkers of exposure and activity.

Participating Sites:

Eligibility Requirements:

  • histologically confirmed malignant melanoma, squamous cell carcinoma, soft tissue sarcoma, or mammary carcinoma
  • measurable disease that is amenable to biopsy
  • favorable performance status
  • both newly diagnosed dogs and those with recurrent/relapse or metastatic disease are eligible
  • No 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

Publication: A Comparative Oncology Study of Iniparib Defines Its Pharmacokinetic Profile and Biological Activity in a Naturally-Occurring Canine Cancer Model, PLoS One

Purpose:

An open label, prospective preclinical trial of orally administered rapamycin will be conducted in dogs with any solid malignancy (excluding mast cell tumor and lymphoma). The study period will be 26 days. Dogs will remain at the COTC site from Day 1-3 and will return for rechecks on Days 8, 19, and 26.

  • histologically or cytologically confirmed solid malignancy (excluding mast cell tumor and lymphoma)
  • favorable performance status
  • both newly diagnosed dogs and those with recurrent/relapse disease are eligible

Purpose:

An open label, prospective preclinical trial of orally administered rapamycin will be conducted in dogs with any solid malignancy (excluding mast cell tumor and lymphoma). The study period will be 26 days. Dogs will remain at the COTC site from Day 1-3 and will return for rechecks on Days 8, 19, and 26.

  • histologically confirmed lymphoma or soft tissue sarcoma
  • measurable disease that is amenable to biopsy
  • favorable performance status
  • both newly diagnosed dogs and those with recurrent/relapse disease are eligible
  • No 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

Publication: NCI Comparative Oncology Program Testing of Non-Camptothecin Indenoisoquinoline Topoisomerase I Inhibitors in Naturally Occurring Canine Lymphoma, Clinical Cancer Research

Purpose:

All dogs will receive standard of care. Standard of care includes surgical removal of tumor and four doses of carboplatin chemotherapy. Dogs will then receive 3 doses of a HER2-targeting bacterial vaccine. The antimetastatic effects of the vaccine will be compared to standard of care alone. 100 dogs will be enrolled on this study.

Sponsor: Morris Animal Foundation

Study Numbers: 100 dogs anticipated

Status: Completed

Participating Sites:

Purpose:

This clinical trial sponsored by the National Cancer Institute (NCI) assesses the safety and effectiveness of an oral investigative agent when given to dogs with cancer. The trial design is a fixed schedule, dose escalation study. The observation period will be 22 days.

Sponsor: National Cancer Institute

Study Numbers: 18-20 dogs

Status: Completed

Eligibility Requirements

  • Histologically confirmed cancer (dogs with mast cell tumors or hemangiosarcoma are not eligible)
  • Measurable disease that is amenable to biopsies
  • Favorable performance status
  • Both newly diagnosed and those with recurrent/relapse disease are eligible

Participating Sites:

Publication: Comparative Oncology Assessment of a Novel Inhibitor of Valosin-Containing Protein in Tumor-Bearing Dogs

Purpose:

Standard therapy for dogs diagnosed with osteosarcoma has long been amputation of the affected limb followed by chemotherapy to prevent or slow the growth and spread of cancer. With this form of treatment, survival times of dogs diagnosed with osteosarcoma is on average about 10 to 12 months with little improvement in survival occurring over the past two decades. The purpose of this study is to evaluate the addition of immunotherapy with an inhaled IL-15 (an immune stimulatory molecule called a cytokine) to the standard treatment in patients with osteosarcoma to see if it improves outcome.

Participating Sites:

Sponsor: University of California at Davis

Study Numbers: 30 dogs will be enrolled 

Eligibility Requirements:

  • Dogs must be more than 25kg
  • Histologically or cytologically confirmed diagnosis of osteosarcoma of the leg for which owners plan to pursue amputation
  • Favorable performance status
  • No prior treatment with chemotherapy, radiation therapy, or bisphosphonates
  • No evidence of metastatic disease