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

NCT03007030 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 2016-0514NCI-2017-00069
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malignant Mesothelioma; CD30-Positive Neoplastic Cells Present

Outcome Measures

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.

  At 4 months

Secondary Outcomes (4)

• Tumor characteristics

  Up to 5 years

• Time to progression

  Up to 5 years

• Overall survival

  Up to 5 years

• CD30+ expression levels

  Up to 5 years

Other Outcomes (2)

• Cytokines in peripheral blood

  At time of disease progression, assessed up to 5 years

• Reverse phase protein array (RPPA) in peripheral blood

  At time of disease progression, assessed up to 5 years

Study Arms (1)

Treatment (brentuximab vedotin)

EXPERIMENTAL

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.

Drug: Brentuximab Vedotin; Other: Laboratory Biomarker Analysis

Interventions

Brentuximab Vedotin DRUG

Given IV

Also known as: ADC SGN-35, Adcetris, Anti-CD30 Antibody-Drug Conjugate SGN-35, Anti-CD30 Monoclonal Antibody-MMAE SGN-35, Anti-CD30 Monoclonal Antibody-Monomethylauristatin E SGN-35, cAC10-vcMMAE, SGN-35

Treatment (brentuximab vedotin)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (brentuximab vedotin)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• Pathologic diagnosis of malignant mesothelioma (any primary site is acceptable, any histology is acceptable)
• Have unresectable malignant mesothelioma (any histology)
• Positive CD30+ immunohistochemical expression
• 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

You may not qualify if:

• 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
• Serious medical or psychiatric illness likely to interfere with participation in this clinical study
• No prior history of malignancy within 2 years, unless cured of a skin cancer or a stage I-III solid tumor; no prior hematologic malignancy within 3 years
• Known hypersensitivity to brentuximab vedotin components
• Persons who are incarcerated at time of enrollment (e.g., prisoners) or likely to become incarcerated during the study

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Mesothelioma, Malignant

Interventions

Brentuximab Vedotin

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Anne S Tsao

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne S. Tsao

CONTACT

713-792-6363; astsao@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2016
• First Posted: December 30, 2016
• Study Start: April 5, 2017
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

US (1)