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Tyrosine Kinase Inhibitor

Cabozantinib + Ifosfamide for Bone Cancer

Phase 1
Recruiting
Led By Theodore Laetsch, MD
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Disease that has progressed on or relapsed after upfront initial therapy, which must have included traditional chemotherapy. A maximum of 2 prior lines of traditional cytotoxic myelosuppressive systemic therapy is allowed.
Age, within the following parameters by cohort: Phase I dose-finding cohort: age 12 to 40 years at the time of enrollment. Phase I dose-confirmation cohort: age 5 to < 12 years at the time of enrollment.
Must not have
Other clinically significant disorders that would preclude safe study participation, including: Cavitating pulmonary lesion. Serious non-healing wound/ulcer/bone fracture. Uncompensated/symptomatic hypothyroidism. Moderate to severe hepatic impairment (Child-Pugh B or C). Recipient of solid organ transplant, known human immunodeficiency virus (HIV) seropositivity, and other non-treatment related immunodeficiencies. Severe or uncontrolled infection or systemic disease. Inadequate electrolyte balance, defined as abnormal levels of serum potassium, calcium, magnesium, and phosphorous and causing clinically significant symptoms, acid-base disturbances, or changes in ECG. Women who are currently pregnant or breastfeeding.
Radiographic evidence of tumor invading major blood vessels, or endotracheal or endobronchial tumor.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up upon completion of accrual to phase 1 cohort, approximately 1 year
Awards & highlights

Summary

This trial tests a drug combo to treat kids & adults with a type of bone cancer (Ewing/osteosarcoma) to see if it's safe & effective.

Who is the study for?
This trial is for children and adults with relapsed/refractory Ewing sarcoma or osteosarcoma who have had prior chemotherapy. Participants must be able to swallow tablets, not pregnant, use contraception, and have a certain body surface area. They should have measurable disease progression but limited previous treatments and good organ function.
What is being tested?
The study tests the safety and effectiveness of cabozantinib combined with high-dose ifosfamide in treating specific sarcomas. It aims to understand how well this drug combination works when other treatments haven't been successful.
What are the potential side effects?
While not explicitly listed here, side effects may include those commonly associated with chemotherapy such as nausea, fatigue, hair loss, increased risk of infection due to low blood cell counts, kidney or liver issues based on the drugs' profiles.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition worsened after initial treatment including chemotherapy, with no more than 2 prior chemotherapy treatments.
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I am between 12 and 40 years old for the dose-finding study, or 5 to under 12 for the dose-confirmation study.
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I can do most activities but may need help, regardless of my age.
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My body surface area is more than 0.35 square meters.
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I can swallow pills without any issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer is affecting major blood vessels or airways.
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My cancer has spread to parts of my digestive system.
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I haven't had chemotherapy that lowers my blood cell counts in the last 14 days.
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I had a bone marrow transplant using my own cells within the last 42 days.
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I haven't had major radiation therapy in the last month and no small area radiation in the last 2 weeks.
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I have healed from any major or minor surgeries before joining the trial.
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I have had severe bladder inflammation from cancer treatment.
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I am not taking any strong medication that affects liver enzymes or prolongs the QT interval.
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I do not have severe heart failure, uncontrolled high blood pressure, recent heart attacks or strokes.
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I do not have active gastrointestinal diseases or recent major GI issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~upon completion of accrual to phase 1 cohort, approximately 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and upon completion of accrual to phase 1 cohort, approximately 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 tolerated dose/recommended phase II dose (MTD/RP2D) of cabozantinib
Secondary outcome measures
Antitumor activity Ewing sarcoma
Antitumor activity osteosarcoma
Dose-limiting toxicities (DLT)
+1 more

Side effects data

From 2022 Phase 2 trial • 45 Patients • NCT02101736
95%
HYPOTHYROIDISM
73%
DIARRHEA
55%
WEIGHT LOSS
50%
FATIGUE
41%
ALANINE AMINOTRANSFERASE INCREASED
41%
Neutrophil Count Decreased
41%
ASPARTATE AMINOTRANSFERASE INCREASED
41%
VOMITING
41%
NAUSEA
41%
ANOREXIA
36%
HEADACHE
36%
PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
36%
PAIN IN EXTREMITY
36%
HYPERTENSION
32%
PROTEINURIA
32%
PAIN
27%
White Blood Cell Count Decreased
27%
ABDOMINAL PAIN
23%
HYPONATREMIA
23%
Platelet Count Decreased
23%
Skin Hypopigmentation
23%
PLATELET COUNT DECREASE
23%
Renal & Urinary Disorders - Other, Ketonuria
23%
Decreased Platelet Count
23%
HAIR COLOR CHANGE
18%
Upper Respiratory Infection
18%
HEMOGLOBIN INCREASED
18%
HYPOKALEMIA
18%
HYPOPHOSPHATEMIA
18%
Alopecia
18%
Hyperkalemia
14%
HYPERGLYCEMIA
14%
Skin And Subcutaneous Disorders - Other, Achromotricia
14%
Pruritis
14%
BILIRUBIN INCREASED
14%
DIZZINESS
14%
ACNEIFORM RASH
14%
Cough
14%
Blood Bilirubin Increased
14%
CONSTIPATION
14%
HYPOGLYCEMIA
14%
Rash Acneiform
14%
Rash Maculopapular
14%
Fever
9%
Papulopustular Rash
9%
Skin And Subcutaneous Tissue Disorders- Other, Rash Unspecified
9%
Back Pain
9%
ABSOLUTE NEUTROPHIL COUNT DECREASED
9%
ALKALINE PHOSPHATASE INCREASED
9%
LIPASE INCREASED
9%
Creatinine Increased
9%
Paresthesia
9%
ORAL PAIN
9%
LYMPHOCYTE COUNT DECREASED
9%
TUMOR PAIN
9%
NASAL CONGESTION
9%
WEIGHT GAIN
9%
HYPOCALCEMIA
9%
DRY SKIN
5%
URINARY URGENCY
5%
Behaviour Disturbance
5%
Injury, Poisoning And Procedural Complications- Other, Scalp Laceration
5%
Investigations - Other, Eosinophilia
5%
Muscle Weakness Lower Limb
5%
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
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, Blister/Bug Bite On Finger
5%
Skin And Subcutaneous Tissue Disorders- Other, Sore On Lips
5%
Skin And Subcutaneous Tissue Disorders- Other, Transient Erythema
5%
Sore Throat
5%
Surgical & Medical Procedures - Other, Dental Extractions
5%
Tachycardia
5%
HYPOMAGNESEMIA
5%
Activated Partial Thromboplastin Time Prolonged
5%
Investigations - Other, International Normalized Ration Increased
5%
Myalgia
5%
Scalp Pain
5%
Gastrointestinal Disorders - Other, Dental Pain
5%
Hypermagnesemia
5%
Hypotension
5%
Infections And Infestations - Other, Gi Viral Infection
5%
Psychiatric Disorders - Other, Mood Swings
5%
DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS
5%
INSOMNIA
5%
Investigations - Other, Increased Mean Corpuscular Volume
5%
Periodontal Disease
5%
Peripheral Sensory Neuropathy
5%
Rash Ezcematoid
5%
Sinus Tachycardia
5%
Infections And Infestations - Other, Covid-19
5%
Peripheral Motor Neuropathy
5%
Tooth Infection
5%
SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE
5%
ANXIETY
5%
Hypertension
5%
JOINT RANGE OF MOTION DECREASED
5%
TENDONITIS
5%
SERUM AMYLASE INCREASED
5%
URINARY FREQUENCY
5%
Conjunctivitis
5%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
Injury, Poisoning And Procedural Complications - Other, Ankle Injury
5%
Muscle Weakness Upper Limb
5%
Musculoskeletal And Connective Tissue Disorders - Other, Extremity Cramps
5%
Neuropathy
5%
Scalp Lesion
5%
Sinusitis
5%
Skin And Subcutaneous Tissue Disorders- Other, Erythema
5%
Stomach Pain
5%
Syncope
5%
RASH
5%
HEMATURIA
5%
Breast Pain
5%
Skin And Subcutaneous Tissue Disorders- Other, New Freckles/Moles
5%
Joint Range Of Motion Decreased
5%
Allergic Rhinitis
5%
SINUS BRADYCARDIA
5%
HYPERTHYROIDISM
5%
Creatine Phosphokinase Increased
5%
Skin And Subcutaneous Tissue Disorders - Other: Blue Lips (Not Cyanosis)
5%
SKIN INFECTION
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

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Cabozantinib
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?

Children's Hospital ColoradoOTHER
117 Previous Clinical Trials
5,132,641 Total Patients Enrolled
Children's Hospital of PhiladelphiaLead Sponsor
721 Previous Clinical Trials
8,604,297 Total Patients Enrolled
1 Trials studying Osteosarcoma
13 Patients Enrolled for Osteosarcoma
Alex's Lemonade Stand FoundationIndustry Sponsor
7 Previous Clinical Trials
1,413 Total Patients Enrolled
1 Trials studying Osteosarcoma
340 Patients Enrolled for Osteosarcoma
~20 spots leftby Nov 2027
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