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Biomarkers in Tumor Tissue Samples From Younger Patients With Rhabdomyosarcoma

N/A
Waitlist Available
Led By Lee Helman, 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
* Alveolar rhabdomyosarcoma and embryonal rhabdomyosarcoma specimens from the Children Oncology Group (COG) tumor microarrays (TMAs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This research trial studies biomarkers in tumor tissue samples from younger patients with rhabdomyosarcoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer

Eligible Conditions
  • Alveolar Rhabdomyosarcoma
  • Childhood Cancer
  • Rhabdomyosarcoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2020 Phase 1 & 2 trial • 88 Patients • NCT02012296
76%
Fatigue
58%
Hot flashes
30%
Diarrhea
30%
Pain
27%
Hyperglycemia
24%
Back pain
18%
Nausea
18%
Dizziness
18%
Dyspnea
18%
Arthralgia
15%
Depression
15%
Anxiety
15%
Anorexia
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: Basic science (biomarker analysis)Experimental Treatment1 Intervention
Archived tumor tissue samples are analyzed for CRKL expression.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,503 Total Patients Enrolled
Children's Oncology GroupLead Sponsor
460 Previous Clinical Trials
239,921 Total Patients Enrolled
Lee Helman, MDPrincipal InvestigatorChildren's Oncology Group
~5 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
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