Natalizumab for Pulmonary Metastatic Osteosarcoma (pOS)

Phase-Based Estimates
1
Effectiveness
1
Safety
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center, Cleveland, OH
+1 More
Natalizumab - Drug
Eligibility
< 65
All Sexes
Eligible conditions
Pulmonary Metastatic Osteosarcoma (pOS)

Study Summary

Natalizumab in Recurrent, Refractory or Progressive Pulmonary Metastatic Osteosarcoma

See full description

Eligible Conditions

  • Osteosarcoma
  • Pulmonary Metastatic Osteosarcoma (pOS)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

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.

Year 1
Clinical benefit rate
Year 1
Dosing limiting toxicity
Up to 3 years
Overall survival measured in months

Trial Safety

Safety Estimate

1 of 3

Side Effects for

Interferon-beta-1b
Injection site reaction
44%
Infection
33%
gastroenteritis
0%
This histogram enumerates side effects from a completed 2011 Phase 4 trial (NCT01144052) in the Interferon-beta-1b ARM group. Side effects include: Injection site reaction with 44%, Infection with 33%, gastroenteritis with 0%.

Trial Design

2 Treatment Groups

Control
Phase I: Natalizumab

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.

Phase I: Natalizumab
Drug
Traditional 3+3 design escalation of Natalizumab at a weight-based dosing 2mg/kg not to exceed a maximum dose of 300mg Phase II treatment to continue if the participant has Complete Response (CR), Partial Response (PR) or Stable Disease (SD) of pOS as defined by RECIST 1.1 criteria after every 3 cycles after the first 6 cycles but not beyond 24 cycles. If the participant has progressive disease after 6 cycles, they will be removed from the study.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Natalizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 3 years for reporting.

Closest Location

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center - Cleveland, OH

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. You must have received 1 prior treatment for Pulmonary Metastatic Osteosarcoma (pOS) or the other condition listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Subjects must have histologic verification of pOS.
Subjects must have measurable pulmonary disease per RECIST 1.1 documented by clinical, radiographic and histologic criteria, and have progressed, relapsed or become refractory to conventional therapy.
Subjects must have recovered from the acute toxic effects with ≤ Grade 1 as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CASE 1718 Page 20 Version date: 9/11/18 CTCAE) Version 5.0 of all prior chemotherapy and immunotherapy with the exception of alopecia, anorexia, bone pain, and tumor pain prior to entering this study.
Myelosuppressive chemotherapy: Must have adequate recovery of counts from previous treatment prior to entry onto this study.
Monoclonal antibodies: At least 3 half-lives must have elapsed since prior therapy that included a monoclonal antibody.
Subjects must have a performance status corresponding to a Karnofsky ≥ 50% for participants > 16 years of age and Lansky ≥ 60 for participants ≤ 16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair will be considered ambulatory for the purpose of assessing the performance score.
Peripheral absolute neutrophil count (ANC) ≥ 750/mcL
Platelet count ≥ 75,000/mcL (transfusion independent)
Hemoglobin ≥ 8.0 g/dL (may receive packed red blood cell transfusions)
Total bilirubin ≤ 1.5 times the upper limit of normal for age

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is pulmonary metastatic osteosarcoma (pos)?

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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.

Unverified Answer

What are common treatments for pulmonary metastatic osteosarcoma (pos)?

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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.

Unverified Answer

What causes pulmonary metastatic osteosarcoma (pos)?

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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.

Unverified Answer

What are the signs of pulmonary metastatic osteosarcoma (pos)?

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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.

Unverified Answer

Can pulmonary metastatic osteosarcoma (pos) be cured?

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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.

Unverified Answer

How many people get pulmonary metastatic osteosarcoma (pos) a year in the United States?

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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.

Unverified Answer

How quickly does pulmonary metastatic osteosarcoma (pos) spread?

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[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.

Unverified Answer

What are the common side effects of natalizumab?

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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).

Unverified Answer

What are the chances of developing pulmonary metastatic osteosarcoma (pos)?

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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.

Unverified Answer

Does pulmonary metastatic osteosarcoma (pos) run in families?

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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.

Unverified Answer

What is the average age someone gets pulmonary metastatic osteosarcoma (pos)?

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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.

Unverified Answer

Who should consider clinical trials for pulmonary metastatic osteosarcoma (pos)?

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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).

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