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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)
Must not have
Radiation therapy to more than 25% of the bone marrow; whole pelvic radiation is considered to be over 25%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had radiation therapy to more than 25% of my bone marrow.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
CD30+ expression levels
Overall survival
Time to progression
+1 moreOther study objectives
Cytokines in peripheral blood
Reverse phase protein array (RPPA) in peripheral blood
Side effects data
From 2018 Phase 3 trial • 131 Patients • NCT0157849947%
Peripheral sensory neuropathy
36%
Nausea
27%
Diarrhoea
27%
Fatigue
17%
Vomiting
17%
Pruritus
15%
Alopecia
15%
Decreased appetite
14%
Pyrexia
12%
Myalgia
12%
Arthralgia
11%
Asthenia
11%
Oedema peripheral
11%
Rash maculo-papular
11%
Dyspnoea
11%
Pruritus generalised
9%
Paraesthesia
9%
Pain in extremity
9%
Weight decreased
9%
Hypertension
8%
Dysgeusia
8%
Headache
8%
Urticaria
8%
Neutropenia
8%
Hyperglycaemia
6%
Peripheral motor neuropathy
6%
Dizziness
6%
Chills
6%
Upper respiratory tract infection
6%
Hyperuricaemia
6%
Urinary tract infection
6%
Muscle spasms
5%
Anaemia
5%
Constipation
5%
Alanine aminotransferase increased
3%
Skin infection
3%
Insomnia
3%
Cough
3%
Cellulitis
2%
Drug eruption
2%
Cancer pain
2%
Diverticulitis
2%
Sepsis
2%
Impetigo
2%
Sinusitis
2%
Extravasation
2%
General physical health deterioration
2%
Multiple organ dysfunction syndrome
2%
Neuropathy peripheral
2%
Musculoskeletal chest pain
2%
Hypotension
2%
Dry skin
2%
Peripheral swelling
2%
Hypertriglyceridaemia
2%
Lower respiratory tract infection
2%
Fracture
2%
Lymphoma
2%
Neck pain
2%
Hepatocellular injury
2%
Intestinal perforation
2%
Haemolytic uraemic syndrome
2%
Pancreatitis
2%
Pulmonary embolism
2%
Urinary retention
2%
Stress
2%
Aspartate aminotransferase increased
2%
Staphylococcal skin infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Brentuximab Vedotin
Methotrexate or Bexarotene
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 3
~1080
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,945 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,039 Previous Clinical Trials
1,799,646 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.
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