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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
Any line of prior therapy - patients may be chemo-naive or chemo-refractory (any line)
Patients must have measurable disease by modified Response Evaluation Criteria in Solid Tumors (RECIST) or RECIST; examinations for assessment of measurable disease must have been completed within 28 days prior to registration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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 below
Select...
I may or may not have received chemotherapy before.
Select...
My cancer can be measured and was checked within the last 28 days.
Select...
I am able to care for myself and perform daily activities.
Select...
I have been diagnosed with malignant mesothelioma.
Select...
My mesothelioma cannot be removed with surgery.
Select...
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.
Select...
My cancer cells test positive for CD30.
Select...
I am a woman who is post-menopausal, surgically sterilized, or will use birth control during and 6 months after the study.
Select...
My kidneys are functioning well enough (creatinine clearance >= 30 mL/min).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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 more
Other outcome measures
Cytokines in peripheral blood
Reverse phase protein array (RPPA) in peripheral blood

Side effects data

From 2020 Phase 4 trial • 60 Patients • NCT01990534
18%
Pyrexia
12%
Peripheral sensory neuropathy
10%
Neuropathy peripheral
10%
Neutropenia
10%
Diarrhoea
8%
Polyneuropathy
8%
Anaemia
8%
Nausea
8%
Upper respiratory tract infection
7%
Vomiting
7%
Decreased appetite
7%
Arthralgia
5%
Hypomagnesaemia
5%
Paraesthesia
5%
Asthenia
5%
Hypokalaemia
5%
Bronchitis
5%
Cough
5%
Alopecia
3%
Nasopharyngitis
3%
Neutrophil count decreased
3%
Back pain
3%
Bone pain
3%
Headache
3%
Depression
3%
Oral herpes
3%
Thrombocytopenia
3%
Tachycardia
3%
Abdominal pain
3%
Constipation
3%
Subcutaneous abscess
3%
Alanine aminotransferase increased
3%
Aspartate aminotransferase increased
3%
Pruritus
3%
Rash
2%
General physical health deterioration
2%
Hodgkin's disease
2%
Anaphylactic reaction
2%
Lymphoedema
2%
Upper respiratory tract inflammation
2%
Renal tubular disorder
2%
Genital haemorrhage
2%
Catheter site inflammation
2%
Chest pain
2%
Chills
2%
Malaise
2%
Oedema
2%
Oedema peripheral
2%
Soft tissue inflammation
2%
Temperature regulation disorder
2%
Vaccination site pain
2%
Liver disorder
2%
Breast cellulitis
2%
Blood lactate dehydrogenase increased
2%
Blood thyroid stimulating hormone increased
2%
Gamma-glutamyltransferase increased
2%
Lymphocyte count decreased
2%
Platelet count decreased
2%
Weight decreased
2%
Hyperglycaemia
2%
Hyperuricaemia
2%
Pain in extremity
2%
Autonomic neuropathy
2%
Dysgeusia
2%
Facial nerve disorder
2%
Somnolence
2%
Insomnia
2%
Device related infection
2%
Herpes zoster
2%
Hordeolum
2%
Extravasation
2%
Fatigue
2%
Conjunctivitis
2%
Coxsackie viral infection
2%
Dengue fever
2%
Influenza
2%
Klebsiella infection
2%
Toothache
2%
Leukocytosis
2%
Leukopenia
2%
Ear pain
2%
Autoimmune thyroiditis
2%
Diplopia
2%
Pseudomonas infection
2%
Sinusitis
2%
Viral infection
2%
Contusion
2%
Ligament sprain
2%
Procedural pain
2%
Blood alkaline phosphatase increased
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

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 (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
~1100

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,586 Previous Clinical Trials
41,242,171 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,946 Previous Clinical Trials
1,803,427 Total Patients Enrolled
Anne S TsaoPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
270 Total Patients Enrolled

Media Library

Brentuximab Vedotin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03007030 — Phase 2
Cutaneous T-Cell Lymphoma Research Study Groups: Treatment (brentuximab vedotin)
Cutaneous T-Cell Lymphoma Clinical Trial 2023: Brentuximab Vedotin Highlights & Side Effects. Trial Name: NCT03007030 — Phase 2
Brentuximab Vedotin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03007030 — Phase 2

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
~1 spots leftby Apr 2024