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New treatment option for CD30-Positive Neoplastic Cells Present
Official title Brentuximab Vedotin in Treating Patients With CD30+ Malignant Mesothelioma That Cannot Be Removed by Surgery
ClinicalTrials.gov ID: NCT03007030
What this study is testing
What is Brentuximab Vedotin?
Brentuximab Vedotin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cd30-positive neoplastic cells present.
Also referred to as ADC SGN-35, Adcetris.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that...
- 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...
- Male subject, even if surgically sterilized (i.e., status postvasectomy), agrees to use an acceptable barrier method for contraception (condom with a...
- Absolute neutrophil count (ANC) \> 1500/mm\^3
- Platelets \> 100,000/mm\^3
You likely can't join 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...
- 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...
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.