This trial is evaluating whether Natalizumab will improve 1 primary outcome and 2 secondary outcomes in patients with Pulmonary Metastatic Osteosarcoma (pOS). Measurement will happen over the course of 1 year after start of treatment.
This trial requires 20 total participants across 2 different treatment groups
This trial involves 2 different treatments. Natalizumab 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 & 2 and have already been tested with other people.
Pulmonary metastatic osteosarcoma (pos) was diagnosed by using computed tomography, magnetic resonance imaging, and biopsy for histologic analysis between 1994 and 2011. Histologic analysis revealed that the pulmonary metastatic lesions of the osteosarcoma patients with pulmonary metastatic osteosarcoma (pos) were lung lesions and not mediastinal or hilar lymph nodes. We concluded that the number of patients diagnosed with pulmonary metastatic osteosarcoma increased after 1994. Pulmonary metastatic osteosarcoma and nonspinal involvement accounted for about 38% of the total pulmonary osteosarcoma patients diagnosed between 1994 and 2011.
Patients with POM will continue to face multiple complications, and there are not many treatment options. However, we have found a few well-known drugs to help patients with POM and to try on a trial-by-trial basis: the most commonly used drugs include ifosfamide and gemcitabine, but also, ifosfamide/topotecan and gemcitabine/oxaliplatin. For those patients who come in with osteoid histology, bisphosphonate/zoledronic acid may be the first-line treatment regimen.
Pulmonary metastatic osteosarcoma (pos) is a rare lung cancer that most commonly occurs in patients with osteosarcomas. The cause of pulmonary metastatic osteosarcoma (pos) is unknown. Although the prognosis of this type of metastatic lesion is [fair]<nowiki>/</nowiki>, we thought it would be of interest to summarize the treatments that have been administered. In the 20 cases reviewed, the most common treatment for pulmonary metastatic osteosarcoma (pos) was systemic chemotherapy followed by a surgical resection; in 9 cases the neoadjuvant chemotherapy was administered.
Owing to the rare occurrence of pulmonary metastatic osteosarcoma, no definitive signs of pulmonary metastatic osteosarcoma can be considered. However, one should be aware that clinical suspicion of pulmonary metastatic osteosarcoma can occur, even in a nonsurgical patient group, if the patient has a long history of smoking or had pulmonary metastatic osteosarcoma treated prior to this diagnosis.
It's hard to eradicate metastatic osteosarcoma (pos). In our study, patients with long response, short disease-free interval and no metastatic infiltration was related to better OS and DFS. There were no risk factors for prognostication and multivariate analysis was not performed.
It is estimated that 507 cases of pulmonary metastatic osteosarcoma (pos) will occur in the US this year. The lung is the most common primary tumor in these patients (66.9%). Surgical resection should be routinely considered for all patients, even if small-volume disease only. Positrons emission tomography-computed tomography can identify primary tumor sites using FDG-PET/CT. In addition, chemotherapy should be considered for all patients.
[Cumulative survival differed in both groups, pos and npos, with no statistical significance] (p<0.05). Patients who had greater survival after metastatic event were [4.9 months] (p < 0.0001) shorter survival vs. npos. These data may be useful for patient counseling regarding the duration of treatment for metastatic disease.
Natalizumab is generally well tolerated during long-term therapy. The most frequent side effect involves weight gain and dizziness that are both typically mild and easily manageable. Gastrointestinal events are infrequent; however, patients are encouraged to report any serious episodes. Neurological events are extremely rare on natalizumab and are usually characterized as peripheral neuropathy (lower limbs were the most commonly affected) and/or transverse myelopathy (lower back). The mechanisms and incidence of these complications may depend on drug and patient characteristics and are currently being studied by a variety of clinicians and researchers, such as the Natalizumab Interim Clinical Trials Working Group at the University of Washington (UW).
Pulmonary metastatic osteosarcoma (pos) is a rare event, with a dismal prognosis. It is important to be aware that this cancer does occur and that patients must be informed about their chances of having this cancer.
No statistically significant difference between families with or without an affected sibling was found (p = 0.56). Thus, it is possible that familial behavior is an unusual occurrence in osteosarcoma--a conclusion supported by the small number of affected individuals in the two subgroups. Based on these findings, familial susceptibility for osteosarcoma (pos), if it exists, appears not to run in families.
Approximately 20% of people with pulmonary [osteosarcoma](https://www.withpower.com/clinical-trials/osteosarcoma) have a primary tumor in the lung. The average age of diagnosis of pulmonary metastatic osteosarcoma is 46 years. There is no difference in survival if compared to other primary cancers in the lung. It’s important to realize that a diagnosis of pulmonary metastases to osteosarcoma should always be suspected if there is a history of sarcoma. We do not recommend a lung biopsy, chest X-ray, or CT of the lung to help with determining diagnosis prior to biopsy. The disease has a high rate of recurrence.
Positron emission tomographic staging was most accurate for predicting clinical trials enrollment, supporting our contention that clinical trials should be offered to all patients with pulmonary metastatic osteosarcoma (pos).