Your session is about to expire
← Back to Search
Monoclonal Antibodies
Tumor Treating Fields + Chemotherapy for Cancer
Phase 1
Recruiting
Led By Apostolia Tsimberidou, MD,PHD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 2 to 3 years
Awards & highlights
Study Summary
This trial is testing the safety and efficacy of a new cancer treatment involving electrical fields and two different drugs.
Who is the study for?
This trial is for adults with advanced solid tumors in the abdomen or thorax, who are physically able to handle treatment (ECOG 0-1), have a life expectancy over 3 months, and meet certain blood count criteria. They must not be pregnant/breastfeeding, agree to use contraception, and should not have severe medical conditions or allergies that conflict with the treatments.Check my eligibility
What is being tested?
The trial tests Tumor Treating Fields Therapy using NovoTTF devices combined with cabozantinib or nab-paclitaxel plus atezolizumab. It aims to find safe doses and see how well these combinations control cancer by disrupting cell division, blocking tumor growth signals, killing cancer cells directly, and boosting immune responses against cancer.See study design
What are the potential side effects?
Possible side effects include skin irritation from device adhesives or hydrogel; reactions related to immunotherapy like inflammation of organs; issues from kinase inhibitors such as high blood pressure; chemotherapy-related nausea, hair loss; fatigue; increased risk of infections due to weakened immune system.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 2 to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 2 to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To assess the safety and tolerability of TTF, including the maximum tolerated dose (MTD).
Secondary outcome measures
To assess the objective response rate, progression-free survival and overall survival
Side effects data
From 2016 Phase 3 trial • 50 Patients • NCT0201927770%
Diarrhoea
68%
Fatigue
56%
Neuropathy peripheral
54%
Alopecia
52%
Rash
46%
Nausea
38%
Upper respiratory tract infection
36%
Myalgia
34%
Vomiting
34%
Headache
28%
Muscle spasms
24%
Nail disorder
24%
Gastrooesophageal reflux disease
24%
Epistaxis
24%
Arthralgia
22%
Pain in extremity
20%
Back pain
20%
Urinary tract infection
18%
Dizziness
18%
Cough
18%
Constipation
16%
Neutropenia
16%
Dry skin
14%
Pyrexia
14%
Paronychia
14%
Dysgeusia
14%
Oropharyngeal pain
14%
Pruritus
14%
Hot flush
12%
Hypertension
12%
Dry eye
12%
Stomatitis
12%
Decreased appetite
12%
Musculoskeletal pain
12%
Insomnia
12%
Dyspnoea
10%
Peripheral sensory neuropathy
10%
Abdominal pain
10%
Mucosal inflammation
10%
Lethargy
8%
Febrile neutropenia
8%
Rash pustular
8%
Lacrimation increased
8%
Chills
8%
Anaemia
8%
Oedema peripheral
8%
Oral candidiasis
8%
Sinusitis
8%
Anxiety
8%
Rhinorrhoea
8%
Acne
8%
Erythema
6%
Musculoskeletal chest pain
6%
Injection site reaction
6%
Skin lesion
6%
Conjunctivitis
6%
Nail infection
6%
Chest pain
6%
Tachycardia
6%
Abdominal pain upper
6%
Dry mouth
6%
Dyspepsia
6%
Chest discomfort
6%
Pain
6%
Hypocalcaemia
6%
Bone pain
6%
Depression
6%
Dyspnoea exertional
6%
Dermatitis acneiform
6%
Lymphoedema
6%
Weight decreased
6%
Tooth extraction
4%
Pulmonary embolism
4%
Cellulitis
2%
Psychotic disorder
2%
Syncope
2%
Dermatitis bullous
2%
Gastroenteritis
2%
Femur fracture
2%
Breast cancer
2%
Device related infection
2%
Wound infection
2%
Cardiac failure
2%
Drug hypersensitivity
2%
Gastritis
2%
Dermatomyositis
2%
Oesophagitis
2%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab, Pertuzumab, and Taxane
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2 (TFF, atezolizumab, nab-paclitaxel)Experimental Treatment3 Interventions
Patients receive TTF continuously for at least 18 hours per day on days 1-28 of each cycle. Patients also receive nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 of each cycle and atezolizumab IV over 30-60 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Cohort 1 (TTF, cabozantinib)Experimental Treatment2 Interventions
Patients receive TTF continuously for at least 18 hours per day on days 1-21 of each cycle. Patients also receive cabozantinib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib S-malate
2013
Completed Phase 2
~470
Nab-paclitaxel
2014
Completed Phase 3
~2030
Atezolizumab
2017
Completed Phase 3
~5860
Tumor Treating Fields Therapy
2018
Completed Early Phase 1
~30
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,278 Total Patients Enrolled
148 Trials studying Breast Cancer
63,286 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,925,838 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Apostolia Tsimberidou, MD,PHDPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.My bone marrow is functioning normally.I haven't had cancer treatment or radiation in the last 2 weeks.I have fully recovered from side effects of my previous cancer treatment.I am eligible for the Cabozantinib treatment group.I am 18 years old or older.I am eligible for the Atezolizumab study group.My liver is working well.I have active cancer spread to my brain or its coverings.I do not have any severe or uncontrolled medical conditions.My advanced cancer in the abdomen or chest has worsened despite standard treatments.I have liver cancer with good liver function, no severe fluid in the abdomen, and no risk of serious bleeding or wound issues.I have a heart condition.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1 (TTF, cabozantinib)
- Group 2: Cohort 2 (TFF, atezolizumab, nab-paclitaxel)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What pathologies does Nab-paclitaxel typically manage?
"Nab-paclitaxel is often prescribed for small cell lung cancer (SCLC) treatment. It has also proved to be beneficial in the management of other malignant neoplasms, as well as previously treated with anti-VEGF and high risk patients."
Answered by AI
What is the upper limit for participants in this research project?
"Affirmative. Per the information on clinicaltrials.gov, this medical study is actively recruiting patients. It debuted April 29th 2022 and was most recently revised September 30th 2022; 36 volunteers are needed from 1 trial site."
Answered by AI
Does this research endeavor break new ground in the field?
"Nab-paclitaxel has been the subject of clinical investigation since 2008, when Hoffmann-La Roche launched their first study with 720 participants. After passing Phase 2 drug approval, 446 active studies have sprung up around the world in 1911 cities and 75 countries."
Answered by AI
Is Nab-paclitaxel a hazard to human health?
"The safety of Nab-paclitaxel is rated a 1, given the Phase 1 status of this trial and limited evidence for both efficacy and protection from harm."
Answered by AI
Is there an open call for participants in this clinical experiment?
"As per the records on clinicaltrials.gov, this trial is presently enrolling participants; it was first published in late April 2022 and had been modified as recently as September 30th of that same year."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger