This trial is evaluating whether Nivolumab will improve 1 primary outcome and 5 secondary outcomes in patients with Osteosarcoma. Measurement will happen over the course of Approximately 4 months.
This trial requires 48 total participants across 2 different treatment groups
This trial involves 2 different treatments. Nivolumab 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 2 and have already been tested with other people.
Osteosarcoma (the cancer that forms in bone) can present in the limbs, in the abdomen, beneath the skin, or in the chest cavity. Osteosarcoma is typically diagnosed during adolescence or early adulthood. More than 80% of men and > 80% of women with osteosarcoma are at high risk for developing lung and/or pleural metastases. Osteosarcoma can be deadly, with a 3-year survival rate of 21.8 %.
Overall, the standard treatment for osteosarcoma is surgery, and chemotherapy is rarely used. Radiotherapy also rarely treats osteosarcoma. However, for localized tumors that are surgically resectable, chemotherapy with adjuvant radiotherapy improves local control and survival.
The use of chemotherapy with local control (radiation) may aid in the cure of osteosarcoma. There are significant differences in the disease course of osteosarcoma in different patients. Therefore, there is little consensus on what constitutes treatment success, since many tumors regress without treatment. It is the case that in most cases where this regimen has not achieved remission, or the disease has become resistant to treatment, the prognosis is very bad.
Although osteosarcoma is the third most common nonrhabdomyosarcoma soft tissue sarcoma after Ewing sarcoma and leiomyosarcoma, osteosarcoma appears to be much more common in the Western than in the Eastern regions of the United States. We are currently pursuing epidemiological investigation of this possibility.
The signs of osteosarcoma can mimic many others. The combination of the signs presented here should help to distinguish osteosarcoma from other similar conditions, including bone metastasis. The most common presentation of osteosarcoma is painless and non-specific lower back pain that gradually worsens with time. A history of recent radiation therapy, painless swelling of the hip bone, limb-length discrepancy of the legs, and a high serum LDH level, are all suspicious signs of osteosarcoma.
Some data suggest that osteosarcoma is genetically or environmentally related to bone tissue. However, the heterogeneity of osteosarcoma may be related to the combination of environmental exposures early in life, or genetic vulnerabilities during somatic embryogenesis.
A small number of the general population and those of the military have been diagnosed with osteosarcoma presumably by chance or exposure to a carcinogen. Although the rate of new cases of osteosarcoma was significantly higher in males than in females in all age groups, there was not a significant increase of rate of osteosarcoma occurrence in any population subgroups over any specified time interval. In conclusion, there is no good evidence that any particular activity puts an increased risk of developing osteosarcoma. To be more precise, there is no good evidence linking workplace exposures to carcinogens, recreational substances or chemicals to the risk of osteosarcoma development.
There are several different presentations for nivolumab. We will review the basic mechanisms of nivolumab, and its role in treating patients with various cancer types including osteosarcoma.\n\n- Cancer.net : Osteosarcoma : The Cancer Society"
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The present research shows that parents are a major gatekeeper to participation in bone cancer pediatric clinical trials. The findings also point to the need for more rigorous clinical trial participation education and support among families.
Results from a recent clinical trial indicate neither a strong nor a weak link between osteosarcoma and occurrence of hereditary osteosarcoma in Israel. Although patients diagnosed with sporadic osteosarcoma constitute the majority, a small subgroup of patients might carry familial genetic predispositions, and further research is warranted to characterize these familial genetic mechanisms, especially the identification of tumor suppressor genes or genes that confer a more malignant disease phenotype.
Mean lifetime prevalence of osteosarcoma is 5.1 per million person-years. Although the incidence rate is higher for Caucasians than for Asians, the lifetime prevalence in the former group is similar. The age of onset is around the age of 10 (10 yr) and the time from diagnosis is 6.1+/-2 yr in Caucasians. More than 30% of osteosarcomas occur in patients 20 yr or older. Findings from a recent study are consistent with the pattern of age-specific risks seen with other solid tumours in adults. This is likely a consequence of the relatively young age at diagnosis. Age > or =5 yr at diagnosis is associated with an increased risk of metastatic disease.
Nivolumab was well tolerated in this study. Side effects were relatively common, and generally mild. The most common adverse effects were fatigue, headache, nausea, vomiting, itching, and rash. We anticipate that this profile will be similar to the adverse effects observed in the randomized controlled trials. Recent findings are consistent with those reported in patients with advanced cancer.