Health TrialsbyHealthPanel

Brentuximab Vedotin in Treating Patients With CD30+ Malignant Mesothelioma That Cannot Be Removed by Surgery

ConditionsCD30-Positive Neoplastic Cells PresentMalignant Mesothelioma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

This phase II trial studies how well brentuximab vedotin works in treating patients with CD30 positive (+) malignant mesothelioma that cannot be removed by surgery. Monoclonal antibodies, such as brentuximab vedotin, may interfere with the ability of tumor cells to grow and spread.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care

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

Disqualifiers

Radiation therapy to more than 25% of the bone marrow; whole pelvic radiation is considered to be over 25%

Prior allogeneic bone marrow or organ transplantation

Female subject who is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (B-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women

Patient has received other investigational drugs with 14 days before enrollment

Trial design

Design model

Single group

Treatments tested in this trial

  • Brentuximab Vedotin

    Drug

    Given IV

  • Laboratory Biomarker Analysis

    Other intervention

    Correlative studies

Treatment groups

55 Participants
are divided into 1 treatment group
Group A: Treatment (brentuximab vedotin)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

A DCR of 50% or higher is considered as clinically significant. If the trial is not stopped early and all 50 patients are accrued, point estimate along with 95% credible interval will be provided. Logistic regression model will be utilized to assess the effect of patient prognostic factors on the response status if sufficient number of patients with stable disease or better response to the treatment are observed.

Time frame
At 4 months

Secondary outcomes

1

Tumor characteristics

Patients' demographic and tumor characteristics will be analyzed, with categorical variables summarized in frequency tables while continuous variables summarized using mean (plus or minus standard deviation) and median (range). The student t-test/Wilcoxon test and analysis of variance (ANOVA)/Kruskal-Wallis test will be used to compare continuous variables between different patient groups. The chi-square test or the Fisher's exact test will be applied to assess the association between two categorical variables.

Time frame
Up to 5 years
2

Time to progression

The distribution of time-to-event endpoints will be estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important patient characteristics will be made using the log-rank test. Cox proportional hazard regression will be employed for multi-covariate analysis on time-to-event outcomes when appropriate.

Time frame
Up to 5 years
3

Overall survival

The distribution of time-to-event endpoints will be estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important patient characteristics will be made using the log-rank test. Cox proportional hazard regression will be employed for multi-covariate analysis on time-to-event outcomes when appropriate.

Time frame
Up to 5 years
4

CD30+ expression levels

The student t-test/Wilcoxon test and ANOVA/Kruskal-Wallis test will be used to compare CD30+ expression levels by response status.

Time frame
Up to 5 years

Other outcomes

1

Cytokines in peripheral blood

Appropriate statistical approaches will be applied to the exploratory analysis of the cytokines.

Time frame
At time of disease progression, assessed up to 5 years
2

Reverse phase protein array (RPPA) in peripheral blood

Appropriate statistical approaches will be applied to the exploratory analysis of RPPA.

Time frame
At time of disease progression, assessed up to 5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
Apply now