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Retinoid
Cabozantinib + 13-cis-Retinoic Acid for Solid Tumors
Phase 1
Recruiting
Research Sponsored by Peter Zage
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Prior Therapy: Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to study enrolment with the exception of hematologic parameters (absolute neutrophil count, hemoglobin, platelet count), which need to have recovered to meet eligibility criteria
Patients must have had histologic verification of a solid tumor, including tumors of the CNS, at the time of initial diagnosis or relapse, with disease that has progressed on standard therapy, relapsed after standard therapy, or for which no standard curative therapy is known
Must not have
Women who are currently pregnant or breastfeeding
The subject has inability to swallow intact tablets
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This trial is testing a new cancer drug combo to see if it's safe and effective. So far it's looking good, with few side effects.
Who is the study for?
This trial is for children with solid tumors, including CNS tumors, that have worsened or not responded to standard treatments. They must be mostly recovered from previous therapies and have a performance status score of ≥40. Participants need measurable disease and agree to use contraception. Exclusions include severe diseases, uncontrolled blood pressure, recent major surgery or bleeding events, certain anticoagulation therapies, prior cabozantinib treatment, inability to swallow tablets, allogeneic stem cell transplant recipients or TBI patients.
What is being tested?
The study tests the safety and appropriate dosing of cabozantinib combined with 13-cis-retinoic acid in pediatric patients whose solid tumors are resistant to standard care. It aims to find the highest dose that can be given without causing serious side effects (maximum tolerated dose) by gradually increasing doses among participants.
What are the potential side effects?
Potential side effects may include toxic reactions affecting various organs due to cabozantinib and 13-cis-retinoic acid combination therapy. Specific risks could involve gastrointestinal issues like perforation or fistula formation; bleeding complications; high blood pressure; bone marrow suppression leading to low blood counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have recovered from previous cancer treatments, except for some blood counts.
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My cancer was confirmed by a lab test and has gotten worse or returned after standard treatment.
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I can do most activities but need help with some.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant or breastfeeding.
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I cannot swallow whole pills.
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I have had a bone marrow transplant or whole-body radiation.
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My scans show holes in my lung tissue or cancer has spread to major blood vessels.
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I am not on blood thinners for a brain tumor or its spread.
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My blood pressure is high and not controlled by oral medication.
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I am taking blood thinners and do not have brain tumors.
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I have a serious illness that is not under control.
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I have been treated with cabozantinib before.
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I have a GI disorder that could lead to holes or abnormal connections in my digestive tract.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
maximum tolerated dose of cabozantinib plus 13-cis-retinoic acid
Side effects data
From 2022 Phase 2 trial • 45 Patients • NCT0210173695%
HYPOTHYROIDISM
73%
DIARRHEA
55%
WEIGHT LOSS
50%
FATIGUE
41%
Neutrophil Count Decreased
41%
ALANINE AMINOTRANSFERASE INCREASED
41%
ASPARTATE AMINOTRANSFERASE INCREASED
41%
VOMITING
41%
ANOREXIA
41%
NAUSEA
36%
HYPERTENSION
36%
HEADACHE
36%
PAIN IN EXTREMITY
36%
PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
32%
PROTEINURIA
32%
PAIN
27%
White Blood Cell Count Decreased
27%
ABDOMINAL PAIN
23%
PLATELET COUNT DECREASE
23%
HYPONATREMIA
23%
Platelet Count Decreased
23%
Renal & Urinary Disorders - Other, Ketonuria
23%
Skin Hypopigmentation
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%
HYPOGLYCEMIA
14%
Rash Maculopapular
14%
BILIRUBIN INCREASED
14%
ACNEIFORM RASH
14%
Cough
14%
Blood Bilirubin Increased
14%
DIZZINESS
14%
CONSTIPATION
14%
Rash Acneiform
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%
Paresthesia
9%
ORAL PAIN
9%
LYMPHOCYTE COUNT DECREASED
9%
Skin And Subcutaneous Tissue Disorders- Other, Rash Unspecified
9%
WEIGHT GAIN
9%
HYPOCALCEMIA
9%
DRY SKIN
5%
Periodontal Disease
5%
Skin And Subcutaneous Tissue Disorders- Other, Transient Erythema
5%
Hypotension
5%
Joint Range Of Motion Decreased
5%
Skin And Subcutaneous Disorders - Other, Dry Skin Patches
5%
Hypertension
5%
SERUM AMYLASE INCREASED
5%
Muscle Weakness Upper Limb
5%
Investigations - Other, Eosinophilia
5%
ANXIETY
5%
Hypermagnesemia
5%
Rash Ezcematoid
5%
Behaviour Disturbance
5%
Scalp Pain
5%
Psychiatric Disorders - Other, Mood Swings
5%
Sinus Tachycardia
5%
Myalgia
5%
Tooth Infection
5%
JOINT RANGE OF MOTION DECREASED
5%
Skin And Subcutaneous Tissue Disorders - Other, Skin Color Change
5%
Skin And Subcutaneous Tissue Disorders- Other, Sore On Lips
5%
URINARY FREQUENCY
5%
Conjunctivitis
5%
Sinusitis
5%
Syncope
5%
Activated Partial Thromboplastin Time Prolonged
5%
Breast Pain
5%
Peripheral Motor Neuropathy
5%
Scalp Lesion
5%
Sore Throat
5%
Tachycardia
5%
INSOMNIA
5%
URINARY URGENCY
5%
Allergic Rhinitis
5%
Peripheral Sensory Neuropathy
5%
HEMATURIA
5%
RASH
5%
Infections And Infestations - Other, Covid-19
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%
Surgical & Medical Procedures - Other, Dental Extractions
5%
Neuropathy
5%
Investigations - Other, Increased Mean Corpuscular Volume
5%
Skin And Subcutaneous Tissue Disorders- Other, New Freckles/Moles
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: Blue Lips (Not Cyanosis)
5%
Muscle Weakness Lower Limb
5%
Urine Discoloration
5%
DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS
5%
Injury, Poisoning And Procedural Complications - Other, Ankle Injury
5%
Injury, Poisoning And Procedural Complications- Other, Scalp Laceration
5%
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
5%
Musculoskeletal And Connective Tissue Disorders - Other, Extremity Cramps
5%
Skin And Subcutaneous Tissue Disorders- Other, Blister/Bug Bite On Finger
5%
Skin And Subcutaneous Tissue Disorders- Other, Erythema
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
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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: Cabozantinib and 13-cis-retinoic acidExperimental Treatment2 Interventions
Cabozantinib will be given orally once every day with cycles repeated every 4 weeks (28 days, +/- 3 days), with no rest periods between cycles, combined with 13-cis-retinoic acid at 80mg/m2/dose twice daily for two consecutive weeks (14 days) out of every four weeks (28 days, +/- 3 days).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
FDA approved
Isotretinoin
FDA approved
Find a Location
Who is running the clinical trial?
Peter ZageLead Sponsor
ExelixisIndustry Sponsor
121 Previous Clinical Trials
20,140 Total Patients Enrolled