NCT03007030 Brentuximab Vedotin in Treating Patients With CD30+ Malignant Mesothelioma That Cannot Be Removed by Surgery
| NCT ID | NCT03007030 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | CD30-Positive Neoplastic Cells Present |
| Study Type | INTERVENTIONAL |
| Enrollment | 55 participants |
| Start Date | 2017-04-05 |
| Primary Completion | 2027-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 55 participants in total. It began in 2017-04-05 with a primary completion date of 2027-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care * Female subject is either: a. post-menopausal for at least one year before the screening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
Contact & Investigator
Anne S Tsao
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT03007030 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying CD30-Positive Neoplastic Cells Present. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03007030 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03007030 currently recruiting?
Yes, NCT03007030 is actively recruiting participants. Contact the research team at astsao@mdanderson.org for enrollment information.
Where is the NCT03007030 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT03007030 clinical trial?
NCT03007030 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Anne S Tsao at M.D. Anderson Cancer Center. The trial plans to enroll 55 participants.