This trial is evaluating whether ALT803 will improve 2 primary outcomes and 12 secondary outcomes in patients with Sarcoma. Measurement will happen over the course of Up to 28 days.
This trial requires 14 total participants across 2 different treatment groups
This trial involves 2 different treatments. ALT803 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.
Around 55,100 sarcomas are diagnosed each year in the United States. This accounts for almost 2% of all newly diagnosed cancer cases in the world in 2003. The five-year survival rate is 65%; this is among the highest rates ever recorded for any cancer. The average 5-year relative survival rate is 69% when the risk of dying from other causes is accounted for. The overall stage 5 (solid) sarcoma incidence is around 1.2 cases per 100,000 for men and 1.7 for women per year in the United States. The overall age-adjusted incidence rate for solid sarcomas is around 1.8 per 100,000 per year in both women and men in the United States.
The study identified the most common chemotherapy agents for sarcomas for which there were no standard protocols for the management of patients. When a sarcoma was found to be locally advanced, the treatment of choice was surgery followed by concurrent chemotherapy.
Though there are many factors which may trigger the development of sarcomas, their exact cause is unknown. However, they may develop from some sort of cancer. Though there are a few specific types that tend to form in certain places, sarcomas may form at any time, anywhere in the body. Although many people survive sarcoma, the disease is rarely cured.\n
Sarcoma, a cancer that forms in a soft, connective or muscle tissue, is one of the most dangerous forms of cancer. Cancer cells form in the cells that make up the tissues. Sarcomas are characterised by tumour cells that are not capable of differentiation. They are very dangerous and can often be difficult to diagnose. It is difficult to know how many people have cancer, the numbers are changing at a dramatic rate. In the UK 2,000 people die of lung cancer every day. Lung cancer can be diagnosed by an X-ray or a CT scan or it can be suspected by screening programmes. Treatment is a combination of medication and surgery, or radiation or chemotherapy.
Soreness or pain in an extremity often comes as the presenting clinical symptom in sarcoma patients. Other signs of sarcoma include the development of a lump on the skin, fever, skin changes that become painful when touched, or persistent weight loss. Other less common signs of sarcoma include swelling or enlargement of the lymph nodes on the neck, groin, or arms or legs, unexplained weight loss, or signs related to metastatic disease, such as high blood pressure, night sweats, or jaundice. Signs are often the result of an underlying cancer, and the signs themselves frequently are not specific for a particular type of cancer.
There is no cure for sarcoma. The disease is incurable. Survival varies but is better than expected. There is no statistical significance in comparison of various age groups. Survival of sarcoma patients depends on their response to treatment. With proper and timely treatment, many patients can live a full, relatively normal life.
Alt803 is relatively well tolerated and does not result in unacceptable levels of ALT or AST elevations. Alt803 was well tolerated for people receiving doses up to 50mg/kg IM/QXD. Alt803 would be an excellent novel drug candidate for the treatment of people with Hodgkin lymphoma.
Alt803 is almost certainly best suited for use in patients with an inadequate kidney function and/or creatinine clearance (<70 ml/min). It may be more effective when used in combination with gemcitabine as the only agent available for the treatment of pancreatic cancer (when only treatment with Gemcitabine is available). Importantly, Alt803 may be better tolerated when administered concurrently with low dose glucocorticoids as long as these are infused through a central line and do not reach the circulating blood stream; alternatively, dexamethasone can be infused over the course of 24-hours as a subcutaneous injection.
There have been several new discoveries. Current evidence suggests that a combination of chemotherapy, radiotherapy and targeted therapy (using agents such as Bortezomib, valsartan and everolimus) has better results than a single agent (i.e. radiation or chemotherapy). The use of targeted therapy and other agents such as the investigational drug-Liposomal Doxorubicin hydrochloride, also known as Adriamycin DPCP, has been shown to be very safe. Further, an increase in the number of patients that are vaccinated against rabies has significantly reduced the number of rabies related deaths caused by rabid animals.
Alt803 is a drug which achieves significant tumor cell deaths even in patients with preexisting tumors of known genetic aberrations. Alt803 causes significant tumor cell apoptosis without triggering a host antitumor immune response. We showed evidence that Alt803 shows a preferential killing of a tumor cell subset specifically infected with oncogenic Ras and/or activated PI3K. Alt803 is well tolerated by humans. It reduces the number of circulating tumor cells and shows promise as an agent to reduce tumor load in advanced disease.
The most recent advances in the management have been the development of targeted agents, in particular the monoclonal antibodies. The targeted agents include Rituximab, anti-PD-1 antibody and anti-CD20 antibodies. Immunotherapeutical approaches aimed to deplete B cells using low-dose, schedule-dependent immunosuppressants such as Methotrexate and Cyclophospodone have been added in case of relapse or recurrence in some patients with favorable results for the remission of locally recurrent or metastatic disease. Overall the advances in research in the management of sarcomas have been encouraging with some patients suffering long-term control and complete response by the new therapies.