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Tyrosine Kinase Inhibitor
Cabozantinib for Childhood Cancer
Phase 2
Recruiting
Led By Nilay Shah, MD
Research Sponsored by Nationwide Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Surgeries or trauma: Patients must not have had major surgical procedures within 4 weeks
Patient Body Surface Area (BSA): Patients must be ≥0.35 m2 in BSA
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5-8 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will study whether the use of cabozantinib can prevent or slow the recurrent formation of pediatric solid tumors.
Who is the study for?
This trial is for children and young adults (18 months to under 40 years) with high-risk pediatric solid tumors like sarcoma or neuroblastoma, especially if they're at risk of recurrence. Participants need good organ function, no recent surgeries or biopsies, and must be able to swallow tablets. They should not be pregnant and must use contraception.
What is being tested?
The study tests Cabozantinib as a maintenance therapy in patients with minimal disease burden from specific pediatric cancers. It aims to prevent or delay tumor regrowth after initial treatment success, potentially extending disease control or achieving long-term cure.
What are the potential side effects?
Cabozantinib may cause side effects such as tiredness, digestive issues like diarrhea, mouth sores, hand-foot skin reactions, high blood pressure and can affect liver enzymes. Side effects vary among individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I haven't had any major surgeries in the last 4 weeks.
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My body surface area is at least 0.35 square meters.
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My liver is functioning well.
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I am between 18 months and 40 years old.
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I can do most activities but may need help.
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I haven't had lung surgery in the last 4 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5-8 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5-8 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To evaluate the effect of oral daily cabozantinib, administered for up to 12 months, on the one-year progression-free survival of patients with "ultra-high-risk" pediatric solid tumors.
Secondary study objectives
To evaluate the duration of response to cabozantinib, both during drug administration and after discontinuation of cabozantinib at study-defined time points.
To evaluate the effect of oral daily cabozantinib on the one-, two-, and five-year overall survival of patients with "ultra-high-risk" pediatric solid tumors.
To evaluate the effect of oral daily cabozantinib on the two- and five-year progression- free survival of patients with "ultra-high-risk" pediatric solid tumors.
+1 moreSide effects data
From 2022 Phase 2 trial • 45 Patients • NCT0210173695%
HYPOTHYROIDISM
73%
DIARRHEA
55%
WEIGHT LOSS
50%
FATIGUE
41%
ALANINE AMINOTRANSFERASE INCREASED
41%
Neutrophil Count Decreased
41%
ASPARTATE AMINOTRANSFERASE INCREASED
41%
VOMITING
41%
ANOREXIA
41%
NAUSEA
36%
HYPERTENSION
36%
HEADACHE
36%
PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
36%
PAIN IN EXTREMITY
32%
PROTEINURIA
32%
PAIN
27%
White Blood Cell Count Decreased
27%
ABDOMINAL PAIN
23%
PLATELET COUNT DECREASE
23%
HYPONATREMIA
23%
Decreased Platelet Count
23%
Platelet Count Decreased
23%
Skin Hypopigmentation
23%
Renal & Urinary Disorders - Other, Ketonuria
23%
HAIR COLOR CHANGE
18%
Upper Respiratory Infection
18%
HEMOGLOBIN INCREASED
18%
HYPOKALEMIA
18%
HYPOPHOSPHATEMIA
18%
Alopecia
18%
Hyperkalemia
14%
Pruritis
14%
HYPOGLYCEMIA
14%
Rash Acneiform
14%
HYPERGLYCEMIA
14%
Rash Maculopapular
14%
BILIRUBIN INCREASED
14%
ACNEIFORM RASH
14%
Cough
14%
Blood Bilirubin Increased
14%
DIZZINESS
14%
Skin And Subcutaneous Disorders - Other, Achromotricia
14%
CONSTIPATION
14%
Fever
9%
NASAL CONGESTION
9%
TUMOR PAIN
9%
Papulopustular Rash
9%
ALKALINE PHOSPHATASE INCREASED
9%
Creatinine Increased
9%
Back Pain
9%
ABSOLUTE NEUTROPHIL COUNT DECREASED
9%
LIPASE INCREASED
9%
Skin And Subcutaneous Tissue Disorders- Other, Rash Unspecified
9%
Paresthesia
9%
ORAL PAIN
9%
LYMPHOCYTE COUNT DECREASED
9%
WEIGHT GAIN
9%
HYPOCALCEMIA
9%
DRY SKIN
5%
Hypotension
5%
Injury, Poisoning And Procedural Complications - Other, Ankle Injury
5%
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
5%
Hypertension
5%
SERUM AMYLASE INCREASED
5%
Injury, Poisoning And Procedural Complications- Other, Scalp Laceration
5%
Skin And Subcutaneous Tissue Disorders - Other, Skin Color Change
5%
Investigations - Other, Eosinophilia
5%
Allergic Rhinitis
5%
ANXIETY
5%
Hypermagnesemia
5%
Rash Ezcematoid
5%
Behaviour Disturbance
5%
Scalp Pain
5%
Psychiatric Disorders - Other, Mood Swings
5%
URINARY URGENCY
5%
Sinus Tachycardia
5%
Periodontal Disease
5%
Myalgia
5%
Tooth Infection
5%
URINARY FREQUENCY
5%
Conjunctivitis
5%
Sinusitis
5%
Syncope
5%
DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS
5%
Activated Partial Thromboplastin Time Prolonged
5%
Breast Pain
5%
Neuropathy
5%
Peripheral Motor Neuropathy
5%
Scalp Lesion
5%
Skin And Subcutaneous Tissue Disorders - Other: Blue Lips (Not Cyanosis)
5%
Skin And Subcutaneous Tissue Disorders- Other, New Freckles/Moles
5%
Sore Throat
5%
Tachycardia
5%
Joint Range Of Motion Decreased
5%
JOINT RANGE OF MOTION DECREASED
5%
INSOMNIA
5%
Skin And Subcutaneous Disorders - Other, Dry Skin Patches
5%
HEMATURIA
5%
RASH
5%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
Investigations - Other, International Normalized Ration Increased
5%
Infections And Infestations - Other, Gi Viral Infection
5%
Gastrointestinal Disorders - Other, Dental Pain
5%
Stomach Pain
5%
SKIN INFECTION
5%
HYPOMAGNESEMIA
5%
Muscle Weakness Upper Limb
5%
Skin And Subcutaneous Tissue Disorders- Other, Blister/Bug Bite On Finger
5%
Surgical & Medical Procedures - Other, Dental Extractions
5%
Skin And Subcutaneous Tissue Disorders- Other, Erythema
5%
Infections And Infestations - Other, Covid-19
5%
Investigations - Other, Increased Mean Corpuscular Volume
5%
TENDONITIS
5%
SINUS BRADYCARDIA
5%
HYPERTHYROIDISM
5%
Creatine Phosphokinase Increased
5%
SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE
5%
Skin And Subcutaneous Tissue Disorders- Other, Sore On Lips
5%
Skin And Subcutaneous Tissue Disorders- Other, Transient Erythema
5%
Musculoskeletal And Connective Tissue Disorders - Other, Extremity Cramps
5%
Muscle Weakness Lower Limb
5%
Peripheral Sensory Neuropathy
5%
Urine Discoloration
5%
SPINAL CORD COMPRESSION
5%
ANEMIA
5%
PARONYCHIA
5%
BRUISING
5%
HYPOALBUMINEMIA
5%
Ear And Labyrinth Disorders - Other, Impacted Cerumen
5%
Ear Pain
5%
Elevated Amylase
5%
Facial Pain
5%
Gastrointestinal Disorders - Other, Stomatitis
5%
Hoarseness
5%
Laryngitis
5%
Leg Pain
5%
Localized Edema
5%
Lung Infection
5%
Metabolism And Nutrition Disorders - Other, Decreased Oral Intake
5%
Metabolism Other - Decreased Vitamin D
5%
Metbolism And Nutrition Disorders - Other, Hyperchloremia
5%
Mucositis Oral
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort B
Cohort A
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: CabozantinibExperimental Treatment1 Intervention
Enrolled patients will be treated with cabozantinib maleate, tablet formulation, using the recommended Phase 2 dose of 40 mg/m2/day, to a maximum of 420 mg/week. Treatment will be administered in 28- day cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
2020
Completed Phase 2
~2360
Find a Location
Who is running the clinical trial?
ExelixisIndustry Sponsor
121 Previous Clinical Trials
20,072 Total Patients Enrolled
Nationwide Children's HospitalLead Sponsor
348 Previous Clinical Trials
5,227,983 Total Patients Enrolled
Nilay Shah, MDPrincipal InvestigatorNationwide Children's Hospital
1 Previous Clinical Trials
116 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had any major surgeries in the last 4 weeks.I have seizures but am on a stable medication regimen for them.My partner and I agree to use birth control.My body surface area is at least 0.35 square meters.My bone marrow is working well.My liver is functioning well.My pancreas works well.My heart is healthy enough for treatment.I am between 18 months and 40 years old.I can do most activities but may need help.My kidney function is normal or near normal.I have recovered from the side effects of my previous treatment.I haven't had lung surgery in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Cabozantinib
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.
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