Using brentuximab vedotin to treat inoperable CD30+ malignant mesothelioma
Phase II Trial of Adcetris (Brentuximab Vedotin) in CD30+ Malignant Mesothelioma
PHASE2 · M.D. Anderson Cancer Center · NCT03007030
This study is testing if a drug called brentuximab vedotin can help people with inoperable CD30 positive malignant mesothelioma feel better and live longer.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center (other) |
| Drugs / interventions | brentuximab, Radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT03007030 on ClinicalTrials.gov |
What this trial studies
This phase II trial investigates the effectiveness of brentuximab vedotin in patients with CD30 positive malignant mesothelioma that cannot be surgically removed. The study aims to assess the disease control rate after four months of treatment, as well as evaluate response rates, survival outcomes, and safety. Patients will receive the treatment intravenously every 21 days, and their progress will be monitored through follow-up visits. Additionally, the study will explore the correlation between CD30 expression levels in tumor tissue and treatment response.
Who should consider this trial
Good fit: Ideal candidates are patients with unresectable CD30 positive malignant mesothelioma who have previously undergone treatment.
Not a fit: Patients with CD30 negative malignant mesothelioma or those who can undergo surgical removal of their tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with a challenging form of cancer.
How similar studies have performed: Other studies have shown promise with monoclonal antibodies in treating various cancers, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care * Female subject is either: a. post-menopausal for at least one year before the screening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 Exclusion Criteria: * 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
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Anne S Tsao — M.D. Anderson Cancer Center
- Study coordinator: Anne S. Tsao
- Email: astsao@mdanderson.org
- Phone: 713-792-6363
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: CD30-Positive Neoplastic Cells Present, Malignant Mesothelioma