Palliative Care Clinical Trials

Our team is dedicated to clinical research in the field of palliative care. For more information on any of these trials, or to find out if you're eligible to participate, contact Carolyn Revta, Palliative Care Clinical Research Operations Director, crevta@ucsd.edu or 858-822-3614.

Ongoing Studies

3 Questions

Status: Currently recruiting
Eligible: Patients with advanced stage cancer
Given the limited prognosis of advanced cancer patients, understanding and effectively communicating their end-of-life wishes is critical. These discussions should occur in the non-emergent outpatient setting when cancer patients may effectively communicate their wishes. However, social and pragmatic barriers limit advance care planning discussions. This study evaluates one simple, non-threatening innovative approach to address advance care planning using a tool developed by the Doris A. Howell Palliative Care Service called the 3 Questions. The 3 Questions are designed to help patients express their desires for advanced care and successfully identify an informed health care proxy or durable power of attorney. The goal of this study is to determine the proportion of advanced cancer patients who identify a health care proxy implementing the 3 Questions tool versus the historical standard.

PledPharma PP095–PLIANT

Status: Currently recruiting
ClinicalTrials.gov identifier: NCT01619423
Eligible: Patients with metastatic colorectal cancer
The first line of treatment for patients with metastatic colorectal cancer is the combination chemotherapy FOLFOX (5–Fluorouracil, Leucovorin and Oxaliplatin), which is given as an intravenous (IV) infusion every two weeks. Although very effective in treating colorectal cancer, there are a number of side effects associated with this treatment regimen, including decreased white blood cell counts, sensory neuropathy of the hands and feet, and diarrhea. These side effects significantly impact a patient’s ability to tolerate treatment with FOLFOX and often result in dose reduction, dose delays, or early progression to a second line of chemotherapy. PledOx is an experimental drug designed to reduce the incidence and severity of these treatment related side effects. PledOx is a manganese-based treatment designed to reduce the toxic effects of chemotherapy in healthy cells. The goal of this open label phase II study is to assess the efficacy of two different doses of PledOx vs. placebo in protecting against side effects associated with the administration of FOLFOX in patients with metastatic colorectal cancer.

Merck V212-011

Status: Currently recruiting
ClinicalTrials.gov identifier: NCT01254630
Eligible: Cancer patients on chemotherapy
This phase III clinical trial seeks to evaluate the efficacy and safety of an experimental vaccine against herpes zoster in patients with solid tumor or hematologic malignancies. Herpes zoster, commonly known as shingles, is the result of the reactivation of latent varicella zoster, the virus that causes chickenpox. Shingles is characterized by a painful rash and is often accompanied by fever, headache, and malaise. Immuno-compromised patients, such as those who are receiving or have recently received chemotherapy, have a higher incidence of shingles and are at increased risk for developing complications. Though there is a commercial live vaccine available to protect against shingles in older adults, it is not approved for use in immuno-compromised patients. Merck, the company that developed the available vaccine, has developed a new form of the vaccine using virus particles that have been inactivated using gamma-irradiation, limiting the amounts of live virus in the vaccine while preserving the viral components that provoke an immune response. 

Eli Lilly I3S-MC-JABA

Status: Currently recruiting
ClinicalTrials.gov identifier: NCT01340976
Eligible: Patients on chemotherapy with anemia
Anemia is a condition characterized by weakness and/or fatigue and is caused by a low number of circulating red blood cells. The presence of anemia in cancer patients is reported to be between 30% and 90%. Many cancers are associated with inflammation that causes anemia by interfering with the release of iron into the plasma. Hepcidin is a small protein that plays a key role in regulating iron storage by binding to and blocking ferroportin, the protein channel through which iron is released into the blood. LY2787106 is an experimental drug developed by Eli Lilly that is designed to bind to and “capture” hepcidin, preventing it from blocking the flow of iron from cells into the plasma. The goal of this phase I study is to assess safety and effectiveness of LY2787106 in treating hepcidin-related anemia in patients with cancer. 

XBiotech 2012-PT023

Status: Currently recruiting
ClinicalTrials.gov identifier: NCT01767857
Eligible: Colorectal cancer patients
Cachexia is a metabolic weight loss syndrome characterized by an increase in metabolism and a decrease in hunger that leads to rapid and uncontrolled loss of lean body mass in cancer patients. Cachexia has significant impacts on quality of life, prognosis, and a patient’s ability to receive or tolerate chemotherapy. Xilonix is an experimental drug designed to reverse or stabilize weight loss in patients with advanced colorectal cancer. The active agent is an antibody that binds to and diminishes the effect of Interleukin 1-alpha (IL1-alpha), a protein that plays a key role in inflammation. In previous studies, Xilonix has reversed the process of cachexia in patients with progressive, metastatic disease. The primary goal of this study is to evaluate overall survival of colorectal cancer patients receiving Xilonix versus patients receiving standard treatment. This study will also evaluate changes in quality of life and lean body mass between the two groups.

Galil CUC10-BNE04

Status: Currently recruiting
ClinicalTrials.gov identifier: NCT01461252
Eligible: Patients with bone metastases in solid tumor cancers
Bone metastases represent a particularly painful and often debilitating metastatic disease, arising from a number of primary tumor types. Bone metastases can lead to a number of complications including loss of mobility, increased risk of fracture, elevated calcium, and spinal cord compression. Current therapies for painful bone metastases are focused on treating symptoms with radiation, pharmaceuticals, or more chemotherapy. Cryoablation is a well-established procedure in which temperature controlled needles are inserted directly into a tumor to freeze the tumor cells. Temperatures within the ablation zone range between -40 and -20oC, low enough to stop all metabolic processes. This causes direct cell death in the immediate ablation zone and initiates chemical signaling pathways that initiate cell death. This procedure has been used with great success in a number of different tumor types, but has not yet been used in treating bone metastases. This study seeks to evaluate the efficacy of using cryoablation in addition to radiation for the palliation of painful bone metastases. 

RTOG-0631 – Phase II/III Study of Image-Guided Radiosurgery/ SBRT for Localized Spine Metastasis

Status: Currently recruiting
ClinicalTrials.gov identifier: NCT01461252
Eligible: Patients with spine metastases
Spine metastases are a common complication of many primary cancer types. Patients with spine metastases often experience severe back pain and other neurological complications that significantly impact quality of life and function. Traditional treatment for painful spine metastases has been fractionated external beam radiotherapy, but the efficacy of these treatments has varied from patient to patient. It has previously been shown that radiosurgery in which one higher radiation dose is administered in the localized region of the spinal tumor have been effective in rapid pain relief. This trial seeks to evaluate the efficacy of radiosurgery with a single fraction versus conventional external beam radiotherapy in managing pain caused by spinal metastases.


 

Contact

Carolyn Revta
Palliative Care Clinical Research Operations Director
Moores Cancer Center
crevta@ucsd.edu
Phone: 858-822-3614