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Tyrosine Kinase Inhibitor

Cabozantinib for Ewing Sarcoma

Phase 1
Waitlist Available
Led By Steven C DuBois, MD
Research Sponsored by Dana-Farber Cancer Institute
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 year
Awards & highlights

Study Summary

This trial is looking at a new combination of drugs as a possible treatment for Ewing sarcoma and/or osteosarcoma that has come back or is not responding to treatment.

Eligible Conditions
  • Ewing Sarcoma
  • Osteosarcoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerate Dose
Secondary outcome measures
Therapeutic procedure
Objective Response Rate
Progression Free Survival

Side effects data

From 2022 Phase 2 trial • 45 Patients • NCT02101736
95%
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%
DIZZINESS
14%
BILIRUBIN INCREASED
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%
INSOMNIA
5%
Peripheral Sensory Neuropathy
5%
HYPERTHYROIDISM
5%
SINUS BRADYCARDIA
5%
Hypertension
5%
ANXIETY
5%
Sore Throat
5%
Myalgia
5%
SPINAL CORD COMPRESSION
5%
Gastrointestinal Disorders - Other, Stomatitis
5%
Hoarseness
5%
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
5%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
Peripheral Motor Neuropathy
5%
Investigations - Other, Eosinophilia
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%
TENDONITIS
5%
HEMATURIA
5%
Gastrointestinal Disorders - Other, Dental Pain
5%
DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS
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: CABOZANTINIB WITH TOPOTECAN-CYCLOPHOSPHAMIDEExperimental Treatment4 Interventions
Participants will be accrued to dose levels in cohorts of 3 using the 3 + 3 design with a combination of cabozantinib, topotecan and cyclophosphamide. Each study treatment cycle lasts 21 days. Participants may receive up to 17 cycles. Participants will be assigned a specific dose and schedule of the study drugs determined when enrolled in the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Myeloid growth factor
2015
Completed Phase 1
~30
Cabozantinib
2020
Completed Phase 2
~1080
Topotecan
2017
Completed Phase 3
~2400
Cyclophosphamide
1995
Completed Phase 3
~3770

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,936 Total Patients Enrolled
3 Trials studying Ewing Sarcoma
355 Patients Enrolled for Ewing Sarcoma
Steven C DuBois, MDPrincipal InvestigatorDana-Farber Cancer Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Cabozantinib been granted the regulatory blessing of the FDA?

"The lack of data regarding cabozantinib's safety and efficacy led our team to assign it a score of 1."

Answered by AI

What is the sample size for this trial?

"This study is no longer enrolling patients. The trial, posted on December 23rd 2020 and last edited July 5th 2022, has concluded its recruitment process. Those searching for other clinical trials may be interested in the 502 studies actively recruiting those with refractory Ewing sarcoma or 1052 studies involving Cabozantinib that are currently seeking participants."

Answered by AI

Is it possible to become a participant in this clinical investigation?

"This clinical trial is presently accepting applications from 6 to 30 year-olds suffering from refractory ewing sarcoma. Additional requirements include the ability to swallow intact pills and having a Body Surface Area (BSA) between 1.25m2 - 2m2; those with BSA below or above these values are ineligible for enrollment, as it would either result in too great of a deviation or an inability to provide sufficient dose escalation/de-escalation respectively. Furthermore, participants must not have progressed on topotecan/cyclophosphamide combination therapy and osteosarcoma patients must be classified as high grade lesions"

Answered by AI

Are individuals currently enrolling in this experiment?

"At present, the investigation detailed on clinicaltrials.gov is not actively looking for participants; however, it was initially advertised in December 2020 and last updated in July 2022. Despite this study's lack of availability, there are 1554 other medical trials presently searching for volunteers."

Answered by AI

What pathologies has Cabozantinib been traditionally employed to combat?

"Cabozantinib is employed to manage multiple sclerosis, but it also has efficacy in treating leukemia, myelocytic sarcoma and other malignancies."

Answered by AI

Does this trial accommodate participants aged 45 or older?

"Individuals who are between 6 and 30 years old can take part in this research."

Answered by AI

What supplementary research has been conducted on the efficacy of Cabozantinib?

"Presently, Cabozantinib is the focus of 1052 clinical trials worldwide. Of these studies, 200 are in their 3rd phase and most are conducted in Philadelphia, Pennsylvania with 39308 sites hosting trials globally."

Answered by AI

Who else is applying?

How old are they?
< 18
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Cabozantinib With Topotecan-Cyclophosphamide
Steven DuBois, MD 2020. "Cabozantinib With Topotecan-Cyclophosphamide". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04661852.
~3 spots leftby Apr 2025
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