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Tyrosine Kinase Inhibitor
Cabozantinib + Temozolomide for Soft Tissue Sarcoma
Phase 2
Waitlist Available
Led By Mark Agulnik, 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at weeks 6 and 12, then every 2 cycles up to 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
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I am using birth control or my partner is.
Select...
I am not pregnant and can become pregnant.
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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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival (PFS)
Secondary outcome measures
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%
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%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
Myalgia
5%
SPINAL CORD COMPRESSION
5%
SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE
5%
Gastrointestinal Disorders - Other, Stomatitis
5%
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
5%
Hoarseness
5%
Peripheral Motor Neuropathy
5%
Investigations - Other, Eosinophilia
5%
Surgical & Medical Procedures - Other, Dental Extractions
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: 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
~1930
Cabozantinib
2020
Completed Phase 2
~1080
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,081 Total Patients Enrolled
41 Trials studying Leiomyosarcoma
3,046 Patients Enrolled for Leiomyosarcoma
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,388 Total Patients Enrolled
Mark Agulnik, MDPrincipal InvestigatorCity of Hope Medical Center
2 Previous Clinical Trials
90 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many patients are included in this clinical trial?
"Yes, the trial is recruiting patients. According to the listings on clinicaltrials.gov, the study was first advertised on 1/14/2020 and was last updated on 7/11/2022. They are hoping to enroll 72 people at 5 different medical sites."
Answered by AI
What other clinical trials are there that focus on Cabozantinib?
"577 clinical trials have been completed for cabozantinib since its inception in 2002 at the Memorial Sloan Kettering Cancer Center. Out of these, 332 are actively recruiting patients with many of the studies based in Chicago, Illinois."
Answered by AI
Has research like this been conducted before?
"Since its inception in 2002, there have been a total of 332 clinical trials researching cabozantinib in 50 different countries. The very first study was sponsored by Schering-Plough and took place in 2002, involving only 60 patients. However, after the successful completion of the Phase 2 drug trial, cabozantinib received approval for heavier use. Currently, there are 1567 cities across the globe with active studies underway."
Answered by AI
Is Cabozantinib dangerous at the therapeutic dose?
"Given that this is a Phase 2 trial, where there is some preliminary data supporting safety but not yet efficacy, our team has rated the safety of Cabozantinib as a 2."
Answered by AI
Are there any current openings for candidates in this clinical trial?
"This clinical trial, which is currently recruiting patients, was originally posted on January 14th 2020. The listing was most recently updated on July 11th 2022."
Answered by AI
What are the most common conditions that Cabozantinib is used to address?
"Cabozantinib is often used to treat patients who have undergone anti-vegf treatment. This medication can also be helpful for those receiving nitrosourea therapy, as well as high risk patients."
Answered by AI
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