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Observational for Bone Cancer
N/A
Waitlist Available
Led By Mark Ranalli, MD
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights
No Placebo-Only Group
Summary
This trial studies biomarker expression in tissue samples from patients with bone sarcomas. Studying biomarker in tissue samples from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer
Eligible Conditions
- Bone Cancer
- Cancer
- Bone Sarcoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Prevalence of high TF expression
Side effects data
From 2020 Phase 1 & 2 trial • 88 Patients • NCT0201229676%
Fatigue
58%
Hot flashes
30%
Diarrhea
30%
Pain
27%
Hyperglycemia
24%
Back pain
18%
Nausea
18%
Dizziness
18%
Dyspnea
18%
Arthralgia
15%
Anorexia
15%
Depression
15%
Anxiety
15%
Hypertension
15%
Edema limbs
15%
Headache
15%
Pain in extremity
12%
Urinary frequency
12%
Constipation
12%
Cough
12%
Fall
12%
Abdominal pain
12%
Arthritis
12%
Bone pain
9%
Urinary incontinence
9%
Insomnia
9%
Flank pain
9%
Generalized muscle weakness
9%
Genital edema
9%
Hematuria
9%
Memory impairment
9%
Platelet count decreased
9%
Pruritis
9%
Anemia
6%
Renal calculi
6%
Sinus disorder
6%
Confusion
6%
Dyspepsia
6%
Muscle weakness lower limb
6%
Peripheral sensory neuropathy
6%
Renal and urinary disorders - Other
6%
Skin and subcutaneous tissue disorders - Other
6%
Vomiting
6%
Alkaline phosphatase increase
6%
Blood bilirubin increased
6%
Blurred vision
3%
Skin infection
3%
Alopecia
3%
Cystitis noninfective
3%
Fracture
3%
General disorders and administration site conditions - Other
3%
Hypokalemia
3%
Upper respiratory infection
3%
Weight gain
3%
Infections and infestations - Other
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Enzalutamide)
Treatment (Enzalutamide, Mifepristone)
Not Randomized
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: ObservationalExperimental Treatment1 Intervention
Tissue samples are analyzed for tumor factor expression levels by immunohistochemistry.
Find a Location
Who is running the clinical trial?
Children's Oncology GroupLead Sponsor
460 Previous Clinical Trials
239,964 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,018,105 Total Patients Enrolled
Mark Ranalli, MDPrincipal InvestigatorChildren's Oncology Group
2 Previous Clinical Trials
93 Total Patients Enrolled
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