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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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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%
VOMITING
41%
NAUSEA
41%
ASPARTATE AMINOTRANSFERASE INCREASED
41%
ANOREXIA
41%
ALANINE AMINOTRANSFERASE INCREASED
41%
Neutrophil Count Decreased
36%
HEADACHE
36%
PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
36%
PAIN IN EXTREMITY
36%
HYPERTENSION
32%
PAIN
32%
PROTEINURIA
27%
ABDOMINAL PAIN
27%
White Blood Cell Count Decreased
23%
Platelet Count Decreased
23%
Skin Hypopigmentation
23%
HAIR COLOR CHANGE
23%
Renal & Urinary Disorders - Other, Ketonuria
23%
PLATELET COUNT DECREASE
23%
HYPONATREMIA
23%
Decreased Platelet Count
18%
HYPOPHOSPHATEMIA
18%
HYPOKALEMIA
18%
Alopecia
18%
Hyperkalemia
18%
Upper Respiratory Infection
18%
HEMOGLOBIN INCREASED
14%
BILIRUBIN INCREASED
14%
DIZZINESS
14%
Pruritis
14%
ACNEIFORM RASH
14%
Fever
14%
Rash Maculopapular
14%
CONSTIPATION
14%
HYPERGLYCEMIA
14%
HYPOGLYCEMIA
14%
Blood Bilirubin Increased
14%
Cough
14%
Rash Acneiform
14%
Skin And Subcutaneous Disorders - Other, Achromotricia
9%
TUMOR PAIN
9%
ORAL PAIN
9%
ALKALINE PHOSPHATASE INCREASED
9%
WEIGHT GAIN
9%
NASAL CONGESTION
9%
Skin And Subcutaneous Tissue Disorders- Other, Rash Unspecified
9%
ABSOLUTE NEUTROPHIL COUNT DECREASED
9%
LIPASE INCREASED
9%
LYMPHOCYTE COUNT DECREASED
9%
HYPOCALCEMIA
9%
DRY SKIN
9%
Back Pain
9%
Creatinine Increased
9%
Papulopustular Rash
9%
Paresthesia
5%
RASH
5%
Hoarseness
5%
INSOMNIA
5%
HYPERTHYROIDISM
5%
Hypertension
5%
ANXIETY
5%
Sore Throat
5%
Myalgia
5%
SPINAL CORD COMPRESSION
5%
DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS
5%
Peripheral Sensory Neuropathy
5%
Gastrointestinal Disorders - Other, Stomatitis
5%
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
5%
Peripheral Motor Neuropathy
5%
Investigations - Other, Eosinophilia
5%
SINUS BRADYCARDIA
5%
Surgical & Medical Procedures - Other, Dental Extractions
5%
SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE
5%
Stomach Pain
5%
HEMATURIA
5%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
Gastrointestinal Disorders - Other, Dental Pain
5%
TENDONITIS
5%
Musculoskeletal And Connective Tissue Disorders - Other, Extremity Cramps
5%
Facial Pain
5%
HYPOMAGNESEMIA
5%
Allergic Rhinitis
5%
Activated Partial Thromboplastin Time Prolonged
5%
Leg Pain
5%
Muscle Weakness Lower Limb
5%
Muscle Weakness Upper Limb
5%
Psychiatric Disorders - Other, Mood Swings
5%
Scalp Lesion
5%
Scalp Pain
5%
Sinus Tachycardia
5%
Sinusitis
5%
Skin And Subcutaneous Tissue Disorders- Other, Blister/Bug Bite On Finger
5%
Skin And Subcutaneous Tissue Disorders- Other, Erythema
5%
Skin And Subcutaneous Tissue Disorders- Other, Sore On Lips
5%
Skin And Subcutaneous Tissue Disorders- Other, Transient Erythema
5%
Syncope
5%
Tachycardia
5%
Urine Discoloration
5%
JOINT RANGE OF MOTION DECREASED
5%
ANEMIA
5%
PARONYCHIA
5%
BRUISING
5%
SERUM AMYLASE INCREASED
5%
SKIN INFECTION
5%
HYPOALBUMINEMIA
5%
URINARY FREQUENCY
5%
URINARY URGENCY
5%
Behaviour Disturbance
5%
Breast Pain
5%
Conjunctivitis
5%
Creatine Phosphokinase Increased
5%
Ear And Labyrinth Disorders - Other, Impacted Cerumen
5%
Ear Pain
5%
Elevated Amylase
5%
Hypermagnesemia
5%
Hypotension
5%
Infections And Infestations - Other, Covid-19
5%
Infections And Infestations - Other, Gi Viral Infection
5%
Injury, Poisoning And Procedural Complications - Other, Ankle Injury
5%
Injury, Poisoning And Procedural Complications- Other, Scalp Laceration
5%
Investigations - Other, Increased Mean Corpuscular Volume
5%
Investigations - Other, International Normalized Ration Increased
5%
Laryngitis
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
5%
Neuropathy
5%
Periodontal Disease
5%
Rash Ezcematoid
5%
Skin And Subcutaneous Disorders - Other, Dry Skin Patches
5%
Skin And Subcutaneous Tissue Disorders - Other, Skin Color Change
5%
Skin And Subcutaneous Tissue Disorders - Other: Blue Lips (Not Cyanosis)
5%
Skin And Subcutaneous Tissue Disorders- Other, New Freckles/Moles
5%
Tooth Infection
5%
Joint Range Of Motion Decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort B
Cohort A
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
~1760
Find a Location
Who is running the clinical trial?
ExelixisIndustry Sponsor
117 Previous Clinical Trials
19,465 Total Patients Enrolled
3 Trials studying Sarcoma
141 Patients Enrolled for Sarcoma
Nationwide Children's HospitalLead Sponsor
341 Previous Clinical Trials
5,220,420 Total Patients Enrolled
1 Trials studying Sarcoma
50 Patients Enrolled for Sarcoma
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research stand alone or has a similar project been attempted in the past?
"Cabozantinib is being trialed in 116 active clinical trials across 46 countries and 1375 cities. The first trial for Cabozantinib was conducted in 2012 by Exelixis, involving 86 patients. The Phase 2 drug approval stage was completed successfully, and since then 55 more studies have been carried out."
Answered by AI
What is the existing research on Cabozantinib?
"As of now, there are 116 ongoing clinical trials for Cabozantinib with 13 being in Phase 3. Most studies taking place regarding this medication are located in Cordoba and Calabria, however there are 7151 locations conducting these sorts of investigations."
Answered by AI
Would you characterize Cabozantinib as a high-risk medication?
"While there is only limited data surrounding cabozantinib's efficacy, what information is available supports its safety--we've given it a score of 2."
Answered by AI
Who can sign up to participate in this research?
"This study is intended for neuroblastoma patients that are between 18 months and 40 years old-- around 100 people in total will be admitted."
Answered by AI
To date, how many people have signed up to take part in this research?
"That is correct. The information on clinicaltrials.gov affirms that this study, which was first advertised on October 18th 2021, is still recruiting patients. They are currently seeking 100 individuals from 1 medical facility to participate."
Answered by AI
Will this clinical trial be testing on patients that are over 45 years old?
"According to the information available, this clinical trial is seeking patients that fall in the 18 months to 40 years old age bracket. Out of 434 total trials, there are 1464 for patients over 65."
Answered by AI
What are the main indications for Cabozantinib?
"Cabozantinib is a popular treatment for patients who have previously been treated with anti-vegf. Cabozantinib can also be effective in treating other conditions such as advanced renal cell carcinoma (arcc), adrenal medulla, and high risk patients."
Answered by AI
Are we currently looking for new participants in this experiment?
"Yes, as of February 25th, 2022, this clinical trial is still looking for 100 participants across 1 location. The study was first posted on October 18th, 2021."
Answered by AI
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