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Tyrosine Kinase Inhibitor
Cabozantinib + Temozolomide for Soft Tissue Sarcoma
Phase 2
Waitlist Available
Led By Janet Yoon, MD
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects must have adequate organ and bone marrow function based on specified laboratory values
Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception
Must not have
Major surgery within 56 days before the first dose of study treatment
Inability to swallow tablets
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at weeks 6 and 12, then every 2 cycles up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying how well cabozantinib and temozolomide work in treating patients with leiomyosarcoma or other soft tissue sarcoma.
Who is the study for?
This trial is for patients with leiomyosarcoma or other soft tissue sarcomas that can't be surgically removed or have spread. Participants must have a certain level of white blood cells, no more than five prior chemo treatments, controlled brain metastases, and good organ function. They should not be pregnant and must agree to use contraception.
What is being tested?
The study tests the combination of cabozantinib (an enzyme blocker) and temozolomide (a chemotherapy drug) on tumor growth in leiomyosarcoma or other soft tissue sarcomas. The goal is to see if this combo works better than either drug alone.
What are the potential side effects?
Potential side effects include typical reactions from cancer drugs such as fatigue, nausea, risk of infection due to low blood cell counts, liver issues, and possibly heart problems like abnormal heartbeats.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My organ and bone marrow functions are within normal ranges.
Select...
I am using birth control or my partner is.
Select...
I am not pregnant and can become pregnant.
Select...
I have had up to 5 chemotherapy treatments for my recurrent or spreading cancer.
Select...
I understand the study requirements and have signed the consent form.
Select...
My diagnosis is an inoperable or metastatic leiomyosarcoma or another type of soft tissue sarcoma.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had major surgery in the last 56 days.
Select...
I cannot swallow pills.
Select...
I have previously been treated with cabozantinib or temozolomide.
Select...
I am currently taking blood thinners.
Select...
I do not have any severe ongoing illnesses like heart or stomach problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at weeks 6 and 12, then every 2 cycles up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at weeks 6 and 12, then every 2 cycles up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression-free survival (PFS)
Secondary study objectives
Clinical benefit rate (Cohort 1)
Incidence of adverse events
Median progression free rate
+3 moreSide effects data
From 2022 Phase 2 trial • 45 Patients • NCT0210173695%
HYPOTHYROIDISM
73%
DIARRHEA
55%
WEIGHT LOSS
50%
FATIGUE
41%
ALANINE AMINOTRANSFERASE INCREASED
41%
Neutrophil Count Decreased
41%
ASPARTATE AMINOTRANSFERASE INCREASED
41%
VOMITING
41%
ANOREXIA
41%
NAUSEA
36%
PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
36%
HEADACHE
36%
PAIN IN EXTREMITY
36%
HYPERTENSION
32%
PROTEINURIA
32%
PAIN
27%
White Blood Cell Count Decreased
27%
ABDOMINAL PAIN
23%
Decreased Platelet Count
23%
PLATELET COUNT DECREASE
23%
HYPONATREMIA
23%
Platelet Count Decreased
23%
Skin Hypopigmentation
23%
Renal & Urinary Disorders - Other, Ketonuria
23%
HAIR COLOR CHANGE
18%
HEMOGLOBIN INCREASED
18%
HYPOKALEMIA
18%
Upper Respiratory Infection
18%
HYPOPHOSPHATEMIA
18%
Alopecia
18%
Hyperkalemia
14%
Rash Acneiform
14%
Pruritis
14%
Rash Maculopapular
14%
HYPOGLYCEMIA
14%
HYPERGLYCEMIA
14%
BILIRUBIN INCREASED
14%
ACNEIFORM RASH
14%
Cough
14%
Blood Bilirubin Increased
14%
DIZZINESS
14%
Skin And Subcutaneous Disorders - Other, Achromotricia
14%
CONSTIPATION
14%
Fever
9%
Papulopustular Rash
9%
ALKALINE PHOSPHATASE INCREASED
9%
LIPASE INCREASED
9%
Creatinine Increased
9%
Back Pain
9%
ABSOLUTE NEUTROPHIL COUNT DECREASED
9%
Paresthesia
9%
TUMOR PAIN
9%
Skin And Subcutaneous Tissue Disorders- Other, Rash Unspecified
9%
ORAL PAIN
9%
LYMPHOCYTE COUNT DECREASED
9%
NASAL CONGESTION
9%
WEIGHT GAIN
9%
HYPOCALCEMIA
9%
DRY SKIN
5%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
Allergic Rhinitis
5%
Hypotension
5%
Muscle Weakness Lower Limb
5%
Skin And Subcutaneous Tissue Disorders- Other, Sore On Lips
5%
Musculoskeletal And Connective Tissue Disorders - Other, Extremity Cramps
5%
Skin And Subcutaneous Disorders - Other, Dry Skin Patches
5%
Hypertension
5%
SERUM AMYLASE INCREASED
5%
Behaviour Disturbance
5%
Investigations - Other, Eosinophilia
5%
Sore Throat
5%
JOINT RANGE OF MOTION DECREASED
5%
Joint Range Of Motion Decreased
5%
HEMATURIA
5%
ANXIETY
5%
Hypermagnesemia
5%
Rash Ezcematoid
5%
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
5%
Scalp Pain
5%
DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS
5%
Psychiatric Disorders - Other, Mood Swings
5%
URINARY URGENCY
5%
Sinus Tachycardia
5%
Periodontal Disease
5%
Peripheral Sensory Neuropathy
5%
Scalp Lesion
5%
Myalgia
5%
Tooth Infection
5%
RASH
5%
Gastrointestinal Disorders - Other, Dental Pain
5%
Peripheral Motor Neuropathy
5%
Tachycardia
5%
URINARY FREQUENCY
5%
Conjunctivitis
5%
Neuropathy
5%
Sinusitis
5%
Syncope
5%
Activated Partial Thromboplastin Time Prolonged
5%
Breast Pain
5%
INSOMNIA
5%
Infections And Infestations - Other, Gi Viral Infection
5%
Stomach Pain
5%
TENDONITIS
5%
SKIN INFECTION
5%
HYPOMAGNESEMIA
5%
Muscle Weakness Upper Limb
5%
Skin And Subcutaneous Tissue Disorders - Other, Skin Color Change
5%
Skin And Subcutaneous Tissue Disorders- Other, Blister/Bug Bite On Finger
5%
Surgical & Medical Procedures - Other, Dental Extractions
5%
Investigations - Other, International Normalized Ration Increased
5%
Skin And Subcutaneous Tissue Disorders- Other, Erythema
5%
Infections And Infestations - Other, Covid-19
5%
Investigations - Other, Increased Mean Corpuscular Volume
5%
Skin And Subcutaneous Tissue Disorders- Other, Transient Erythema
5%
SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE
5%
Injury, Poisoning And Procedural Complications - Other, Ankle Injury
5%
Injury, Poisoning And Procedural Complications- Other, Scalp Laceration
5%
Skin And Subcutaneous Tissue Disorders- Other, New Freckles/Moles
5%
SINUS BRADYCARDIA
5%
HYPERTHYROIDISM
5%
Creatine Phosphokinase Increased
5%
Skin And Subcutaneous Tissue Disorders - Other: Blue Lips (Not Cyanosis)
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
Awards & Highlights
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: Treatment (cabozantinib, temozolomide)Experimental Treatment4 Interventions
Patients receive cabozantinib PO QD on days 1-28 and temozolomide PO QD on days 1-5. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
2010
Completed Phase 3
~1880
Cabozantinib
2020
Completed Phase 2
~1760
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,906 Previous Clinical Trials
41,011,960 Total Patients Enrolled
4 Trials studying Uterine Leiomyosarcoma
271 Patients Enrolled for Uterine Leiomyosarcoma
City of Hope Medical CenterLead Sponsor
599 Previous Clinical Trials
1,923,470 Total Patients Enrolled
Janet Yoon, MDPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials
60 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My organ and bone marrow functions are within normal ranges.I am using birth control or my partner is.My brain cancer has not worsened after treatment.I don't have another cancer that could affect this treatment's safety or results.I have not had major surgery in the last 56 days.I am not pregnant and can become pregnant.I haven't had any radionuclide treatment in the last 42 days.I have had up to 5 chemotherapy treatments for my recurrent or spreading cancer.I have taken certain medications recently.I have recovered from side effects of previous treatments to my normal health or have only mild side effects.I understand the study requirements and have signed the consent form.My diagnosis is an inoperable or metastatic leiomyosarcoma or another type of soft tissue sarcoma.I am fully active or restricted in physically strenuous activity but can do light work.I cannot swallow pills.I have previously been treated with cabozantinib or temozolomide.I am currently taking blood thinners.I do not have any severe ongoing illnesses like heart or stomach problems.
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.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (cabozantinib, temozolomide)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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