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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Select...
My cancer was confirmed by a lab test and has gotten worse or returned after standard treatment.
Select...
I can do most activities but need help with some.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
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 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%
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: 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
117 Previous Clinical Trials
19,533 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do any other investigations exist that have utilized Cabozantinib?
"Presently, 124 clinical studies investigating the effects of cabozantinib are underway with 15 in Phase 3. Although most trials take place in Cordoba and Calabria, a considerable quantity is running across 7500 global sites."
Answered by AI
Is Cabozantinib a safe option for those seeking treatment?
"Based on the limited data available, our team at Power judged Cabozantinib's safety and efficacy to be a 1. This rating is reflective of its status as a Phase 1 trial."
Answered by AI
For what medical purpose is Cabozantinib commonly used?
"Cabozantinib is primarily used to treat neuroblastoma, but also has applications for sezary syndrome, high-risk patients, and renal cell carcinoma."
Answered by AI
Does this research initiative permit adults to participate?
"343 medical trials are open to children up to the age of 26, with 2499 studies for seniors over 65. Eligible applicants must meet these age criteria in order to join this research study."
Answered by AI
How many individuals are being selected to participate in this research?
"Affirmative. According to information provided on clinicaltrials.gov, this research is currently searching for participants who posted on August 28th 2018 and last modified October 3rd 2022. The study aims to recruit 18 individuals from single centre."
Answered by AI
What are the qualifications for joining this research endeavor?
"This experiment is accepting 18 participants with cancer who are between the ages of two and twenty-six. The eligibility requirements encompass having histologically verified solid tumors, including those in the CNS, that have advanced or recurred despite standard medical intervention; evidence of either evaluable or measurable disease within four weeks prior to initiating therapy; a Lansky Play/Karnofsky score higher than 40%; and being on stable or decreasing doses of steroids for at least one week before treatment commences (excluding patients harbouring known brain metastases)."
Answered by AI
Are there any vacant spots in this clinical examination?
"Per the information provided by clinicaltrials.gov, this study is presently recruiting participants. This medical trial was first posted on August 28th 2018 and last updated on October 3rd 2022."
Answered by AI
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