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Monoclonal Antibodies
Natalizumab for Metastatic Osteosarcoma
Phase 1 & 2
Recruiting
Led By Kristen VanHeyst, DO
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing a drug to treat osteosarcoma that has spread to the lungs in children, adolescents, and young adults. They will be testing how well the drug works and if it is safe.
Who is the study for?
This trial is for children and young adults with a type of bone cancer that has spread to the lungs (pulmonary metastatic osteosarcoma) and hasn't improved with standard treatments. Participants need normal heart, liver, and marrow function, no severe ongoing illnesses or infections, not be on immunosuppressive therapy or other investigational drugs, and agree to use contraception if applicable.Check my eligibility
What is being tested?
The study tests Natalizumab's safety and how well it works in patients with pulmonary metastatic osteosarcoma. It aims to see if this drug can improve survival rates in those who have not responded well to conventional therapies.See study design
What are the potential side effects?
Natalizumab may cause allergic reactions similar to compounds of its class. There's also a risk of infection due to immune system suppression. Specific side effects are not listed but will relate to the drug’s impact on organ systems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung disease can be measured and has not improved with standard treatments.
Select...
I can do most activities myself, even if I use a wheelchair.
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My bilirubin levels are within the normal range for my age.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dosing limiting toxicity
Secondary outcome measures
Clinical benefit rate
Overall survival measured in months
Side effects data
From 2011 Phase 4 trial • 19 Patients • NCT0114405270%
Infection
10%
gastroenteritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Natalizumab
Interferon-beta-1b
Trial Design
1Treatment groups
Experimental Treatment
Group I: Phase I: NatalizumabExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Natalizumab
2003
Completed Phase 4
~4900
Find a Location
Who is running the clinical trial?
Case Comprehensive Cancer CenterLead Sponsor
452 Previous Clinical Trials
31,890 Total Patients Enrolled
Kristen VanHeyst, DOPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center
Alex Huang, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver is working well.I have side effects from previous treatments, but they are mild except for hair loss, lack of appetite, bone, and tumor pain.My organ and bone marrow functions are normal.My hemoglobin level is at least 8.0 g/dL.I do not have any severe illnesses that would stop me from following the study's requirements.I can understand and am willing to sign the consent form, or if under 18, the assent document.It's been long enough since my last monoclonal antibody treatment.My blood cell counts have recovered from my last chemotherapy.My bone marrow is working well.My lung disease can be measured and has not improved with standard treatments.I can do most activities myself, even if I use a wheelchair.My bilirubin levels are within the normal range for my age.I have or had a brain infection called PML.You are currently taking any other experimental medications.My heart is functioning well.I am not pregnant or breastfeeding.I am not HIV-positive or on HIV treatment.I have recovered from previous cancer treatments, except for hair loss, loss of appetite, bone, or tumor pain.I am a woman able to have children and have a negative pregnancy test.You have had allergic reactions in the past to similar medications like Natalizumab.I am currently taking medication to suppress my immune system.My lung cancer that has spread can be fully removed with surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Phase I: Natalizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this study currently seeking participants?
"Clinicaltrials.gov indicates that this medical research is actively accepting participants, with the initial posting on April 1st 2023 and a recent update posted October 24th 2022."
Answered by AI
To what extent is participation in this experiment widespread?
"Affirmative. According to the data available on clinicaltrials.gov, this study is actively enlisting participants and has been since April 1st 2023. On October 24th 2022, the most recent updates were made; thus far, 20 patients have been admitted from a single location."
Answered by AI
Are individuals aged over 40 being considered for this clinical experiment?
"Recruitment for this medical research is focusing on individuals between 5 and 30 years old."
Answered by AI
Would I be a suitable candidate for this trial?
"Prospective enrollees must have osteosarcoma and fall within the age range of 5-30 years old to qualify for this clinical trial, which is currently limited to 20 participants."
Answered by AI
Can you provide me with a summary of past research conducted involving Natalizumab?
"Currently, there are 7 clinical trials in progress researching the effects of Natalizumab with two being conducted at Phase 3. Although most research on this medication is centered around Fort Collins, Colorado; 173 sites across America are trialing it."
Answered by AI
In what medical scenarios is Natalizumab usually recommended?
"Natalizumab is suitable for cases of intolerance to traditional therapies, when used as a monotherapy, and Crohn's disease."
Answered by AI
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