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Monoclonal Antibodies
Brentuximab Vedotin for Inoperable Mesothelioma
Phase 2
Recruiting
Led By Anne S Tsao
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
Calculated creatinine clearance must be >= 30 mL/minute
Have unresectable malignant mesothelioma (any histology)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial looks at how well brentuximab vedotin works in treating patients with malignant mesothelioma that cannot be removed by surgery. Monoclonal antibodies may help to prevent tumor cells from growing and spreading.
Who is the study for?
This trial is for male and female patients with CD30+ malignant mesothelioma that can't be surgically removed. Participants need to agree to contraception, have had any prior treatments, and their major organs must function well. Exclusions include a recent history of other cancers, significant bone marrow radiation, organ transplants, current participation in other studies, serious health or mental issues, pregnancy or breastfeeding.Check my eligibility
What is being tested?
The study tests Brentuximab Vedotin's effectiveness on patients with inoperable CD30+ malignant mesothelioma. It's a phase II trial where this monoclonal antibody is used to see if it can stop cancer cells from growing and spreading.See study design
What are the potential side effects?
Brentuximab Vedotin may cause side effects such as infusion reactions (like fever or chills), fatigue, nausea or vomiting, diarrhea or constipation, mouth sores, skin rashes or itching. There might also be an increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidneys are functioning well enough (creatinine clearance >= 30 mL/min).
Select...
My mesothelioma cannot be removed with surgery.
Select...
I am able to care for myself and perform daily activities.
Select...
My cancer cells test positive for CD30.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
Disease control rate (DCR) defined as proportion of patients who had complete response, partial response or stable disease by Response Evaluation Criteria in Solid Tumors version 4.1
Secondary outcome measures
CD30+ expression levels
Overall survival
Time to progression
+1 moreOther outcome measures
Cytokines in peripheral blood
Reverse phase protein array (RPPA) in peripheral blood
Side effects data
From 2020 Phase 4 trial • 60 Patients • NCT0199053418%
Pyrexia
12%
Peripheral sensory neuropathy
10%
Diarrhoea
10%
Neuropathy peripheral
10%
Neutropenia
8%
Polyneuropathy
8%
Nausea
8%
Anaemia
8%
Upper respiratory tract infection
7%
Arthralgia
7%
Vomiting
7%
Decreased appetite
5%
Hypomagnesaemia
5%
Hypokalaemia
5%
Paraesthesia
5%
Asthenia
5%
Bronchitis
5%
Cough
5%
Alopecia
3%
Oral herpes
3%
Abdominal pain
3%
Back pain
3%
Aspartate aminotransferase increased
3%
Alanine aminotransferase increased
3%
Constipation
3%
Nasopharyngitis
3%
Neutrophil count decreased
3%
Bone pain
3%
Headache
3%
Depression
3%
Thrombocytopenia
3%
Tachycardia
3%
Subcutaneous abscess
3%
Pruritus
3%
Rash
2%
Anaphylactic reaction
2%
Klebsiella infection
2%
Toothache
2%
Ligament sprain
2%
Chills
2%
Fatigue
2%
Blood alkaline phosphatase increased
2%
Lymphocyte count decreased
2%
Oedema
2%
Procedural pain
2%
Gamma-glutamyltransferase increased
2%
Catheter site inflammation
2%
Chest pain
2%
Renal tubular disorder
2%
Malaise
2%
Hyperuricaemia
2%
Influenza
2%
Lymphoedema
2%
Dengue fever
2%
Blood lactate dehydrogenase increased
2%
Facial nerve disorder
2%
Extravasation
2%
General physical health deterioration
2%
Hodgkin's disease
2%
Blood thyroid stimulating hormone increased
2%
Genital haemorrhage
2%
Upper respiratory tract inflammation
2%
Oedema peripheral
2%
Soft tissue inflammation
2%
Temperature regulation disorder
2%
Vaccination site pain
2%
Liver disorder
2%
Breast cellulitis
2%
Platelet count decreased
2%
Weight decreased
2%
Hyperglycaemia
2%
Pain in extremity
2%
Autonomic neuropathy
2%
Dysgeusia
2%
Somnolence
2%
Insomnia
2%
Device related infection
2%
Herpes zoster
2%
Hordeolum
2%
Conjunctivitis
2%
Coxsackie viral infection
2%
Leukocytosis
2%
Leukopenia
2%
Ear pain
2%
Autoimmune thyroiditis
2%
Diplopia
2%
Pseudomonas infection
2%
Sinusitis
2%
Viral infection
2%
Contusion
2%
Haemoglobin decreased
2%
Pneumonia
2%
Device related sepsis
2%
Septic shock
2%
Urinary tract infection
2%
Serum sickness-like reaction
2%
Cerebrovascular accident
2%
Anxiety
2%
Pleural effusion
2%
Vena cava thrombosis
2%
Dyspnoea
2%
Dyspnoea exertional
2%
Nasal congestion
2%
Dermatitis
2%
Dermatitis acneiform
2%
Dermatitis allergic
2%
Dermatitis contact
2%
Erythema
2%
Pruritus generalised
2%
Rash macular
2%
Rash maculo-papular
2%
Rash papular
2%
Rash pruritic
2%
Urticaria
2%
Haematoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Brentuximab Vedotin 1.8 mg/kg
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (brentuximab vedotin)Experimental Treatment2 Interventions
Patients receive brentuximab vedotin IV over 30 minutes on day 1. Courses 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
Brentuximab Vedotin
2015
Completed Phase 4
~1070
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,799 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,306 Total Patients Enrolled
Anne S TsaoPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
304 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your total bilirubin level is not higher than 1.5 times the upper limit of normal.I agree to use or have used a reliable form of birth control or abstain from sex for the study duration and 6 months after.I am not pregnant or breastfeeding, confirmed by a negative pregnancy test.I am a woman who is post-menopausal, surgically sterilized, or will use birth control during and 6 months after the study.My kidneys are functioning well enough (creatinine clearance >= 30 mL/min).My mesothelioma cannot be removed with surgery.Your white blood cell count is too high.You are allergic to any parts of brentuximab vedotin.I have not had radiation therapy to more than 25% of my bone marrow.Your hemoglobin level is higher than 8.5 grams per deciliter.Your platelet count is higher than 100,000 per cubic millimeter.I may or may not have received chemotherapy before.My cancer can be measured and was checked within the last 28 days.I am able to care for myself and perform daily activities.You have had a bone marrow or organ transplant from someone else in the past.Your liver enzymes (AST and ALT) are within a certain range, except if you have known liver metastases.I haven't had cancer in the past 2 years, except for skin cancer or early-stage solid tumor that was cured.I have been diagnosed with malignant mesothelioma.My cancer cells test positive for CD30.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (brentuximab vedotin)
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.
Has Brentuximab Vedotin been given the green light from the FDA?
"According to our team at Power, Brentuximab Vedotin achieved a score of 2 on the safety scale due to preliminary evidence that suggests it is safe. No data exists yet validating its efficacy."
Answered by AI
Are there any prior investigations involving Brentuximab Vedotin that have been documented?
"Currently, there are 59 ongoing trials for Brentuximab Vedotin with 6 in their third phase. Montvale New jersey is one of the leading locations where studies on this medication occur and across 1851 sites worldwide investigations into its efficacy take place."
Answered by AI
Is this an innovative study with new protocols?
"Presently, Brentuximab Vedotin is being tested in 59 trials across 630 cities and 31 nations. Seagen Inc. initiated the first study for this drug back in 2011; it involved 79 patients and concluded with a Phase 2 approval stage. Since then, 623 more clinical studies have been successfully completed."
Answered by AI
Is it still possible to take part in this clinical experiment?
"Clinicaltrials.gov indicates that this medical trial is actively recruiting participants, with the first post being on April 5th 2017 and an edit occurring as recently as January 3rd 2022."
Answered by AI
To what extent is this research project involving participants?
"Affirmative. Information accessible on clinicaltrials.gov affirms that this medical research is currently enlisting volunteers, after its initial post date of April 5th 2017 and last edit of January 3rd 2022. Specifically, 55 subjects need to be recruited from 1 site."
Answered by AI
To what types of diseases is Brentuximab Vedotin typically prescribed?
"Brentuximab Vedotin is a frequently employed medication for hodgkin disease, as well as systemic anaplastic large cell lymphoma and peripheral t-cell lymphoma. It has also been successfully leveraged in the management of untreated cases."
Answered by AI
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