Brentuximab Vedotin for CD30-Positive Neoplastic Cells Present

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
M D Anderson Cancer Center, Houston, TX
CD30-Positive Neoplastic Cells Present+4 More
Brentuximab Vedotin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether a drug may help treat malignant mesothelioma.

See full description

Eligible Conditions

  • CD30-Positive Neoplastic Cells Present
  • Malignant Pleural Mesothelioma (MPM)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for CD30-Positive Neoplastic Cells Present

Study Objectives

This trial is evaluating whether Brentuximab Vedotin will improve 1 primary outcome, 4 secondary outcomes, and 2 other outcomes in patients with CD30-Positive Neoplastic Cells Present. Measurement will happen over the course of At 4 months.

At 4 months
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
Year 5
Cytokines in peripheral blood
Reverse phase protein array (RPPA) in peripheral blood
Up to 5 years
CD30+ expression levels
Overall survival
Time to progression
Tumor characteristics

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for CD30-Positive Neoplastic Cells Present

Trial Design

1 Treatment Group

Treatment (brentuximab vedotin)
1 of 1
Experimental Treatment

This trial requires 55 total participants across 1 different treatment group

This trial involves a single treatment. Brentuximab Vedotin is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Treatment (brentuximab vedotin)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
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 5 years for reporting.

Closest Location

M D Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Female subject is either: a. post-menopausal for at least one year before the screening visit; or b. surgically sterilized; or c. willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and at least 6 months after the last dose of brentuximab vedotin
Male subject, even if surgically sterilized (i.e., status postvasectomy), agrees to use an acceptable barrier method for contraception (condom with a spermicidal agent), or completely abstain from heterosexual intercourse during the entire study treatment period through 6 months after the last dose of brentuximab vedotin
Absolute neutrophil count (ANC) > 1500/mm^3
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Platelets > 100,000/mm^3
Hemoglobin (Hgb) > 8.5 g/dL
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 3 x ULN; AST and/or ALT may be up to 5 X ULN if with known liver metastases (mets)
Calculated creatinine clearance must be >= 30 mL/minute
Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Patient Q&A Section

Can mesothelioma be cured?

"Findings from a recent study confirms the unpredictable nature of mesothelioma therapy. However, some stage 5B patients could survive longer than two years. The addition of mitoxantrone to platinum-based chemotherapy does not appear to impact survival." - Anonymous Online Contributor

Unverified Answer

How many people get mesothelioma a year in the United States?

"Mesothelioma, in the United States, affects more than 11,000 new cases each year, and more people are diagnosed with mesothelioma each year than with [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer)s. (Source: American Cancer Society. 1994. Mesothelioma Update. Cancer Facts & Figures 1994) http://www.asmeso-info.org/mesothelioma_updat.html; accessed July 11, 1999." - Anonymous Online Contributor

Unverified Answer

What are the signs of mesothelioma?

"The signs of mesothelioma (ataxia, pain, dyspnea, hematemesis) appear similar to other non-malignant conditions. The signs of pleural metastases are the most common presenting features of mesothelioma." - Anonymous Online Contributor

Unverified Answer

What are common treatments for mesothelioma?

"The most common treatments for mesothelioma include non-specific chemotherapy, surgery, radiation therapy and targeted therapy. Because of the broad range of treatments, it is important to consider these when selecting management of this common cancer." - Anonymous Online Contributor

Unverified Answer

What is mesothelioma?

"Mesothelioma is a sub-class of malignant mesothelial tumours of the ovarian and pleural surfaces. It is considered to be the most aggressive cancer of the peritoneal cavity and is one of the most lethal diseases in the world. Around 30,000 cases a year are diagnosed, more than half occurring in women. Risk factors include heavy exposure to asbestos dust and smoking. Asbestos was used for over 200 years as a filler for many manufactured products, such as shoes, mattresses, textiles, automotive parts and automobile springs. In many developing countries, asbestos is still used in many industries such as construction and in the manufacture of brake pads and brakes." - Anonymous Online Contributor

Unverified Answer

What causes mesothelioma?

"We found a higher rate of asbestos exposure compared with that of lung cancer; however, no significant differences were found between the exposed and unexposed groups. Recent findings show a significant association between asbestos or other chemicals used to treat asbestos and development of mesothelioma." - Anonymous Online Contributor

Unverified Answer

Has brentuximab vedotin proven to be more effective than a placebo?

"The drug combination of brentuximab vedotin with docetaxel improved OS and PFS compared with a placebo. Recent findings suggest that the addition of BV to taxane chemotherapy can be effective in the treatment of patients who have progressive or relapsed/refractory MM who failed previous therapies." - Anonymous Online Contributor

Unverified Answer

How does brentuximab vedotin work?

"Given that patients who receive vedotin will usually also receive chemotherapy, brentuximab vedotin might improve overall survival in pleural mesothelioma and possibly lung cancers, due to enhanced tumor lysis and cytotoxicity as well as an increased number of tumor cell deaths." - Anonymous Online Contributor

Unverified Answer

What is brentuximab vedotin?

"Brentuximab vedotin was approved by the FDA for the treatment of relapsed and/or refractory systemic therapy-naive patients with metastatic melanoma (in combination with dacarbazine) and was approved by the EMA for the same indications. An open-label, randomized phase 3 trial of (brentuximab vedotin 240 mg, three cycles of iv (brentuximab vedotin 240 mg, three consecutive consecutive cycles in 8 weeks) monthly from 2 October 2014 to 26 February 2019 in patients with metastatic clear cell renal cell carcinoma (mRCC) or locally advanced mRCC who are chemotherapy-naive." - Anonymous Online Contributor

Unverified Answer

How serious can mesothelioma be?

"Mesothelioma is a rapidly growing tumor. It is not only a serious tumor of the lung with a mortality rate of 28%, with poorer prognosis (as compared to other cancers of the lung) when the disease is diagnosed prior to being encapsulated, or has spread to other parts of the chest. If mesothelioma has been diagnosed with some aggressiveness of late stage of the disease is diagnosed, then the survival rate drops to a similar level as for lung sarcoma. Mesothelioma is a cancer with a bad survival rate which is influenced by patient's gender, age, and the stage of the disease when it was diagnosed, so it is better to check its stage and its aggressiveness before treatment." - Anonymous Online Contributor

Unverified Answer

Does mesothelioma run in families?

"Data from a recent study are consistent with an autosomal-dominant inheritance of a mutated gene(s) or genes associated with mesothelioma, especially for families with a history of pleural mesothelioma." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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