ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial of Adcetris in CD30+ Malignant Mesothelioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03007030
Recruitment Status : Recruiting
First Posted : December 30, 2016
Last Update Posted : December 25, 2018
Sponsor:
Collaborator:
Seattle Genetics, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

The goal of this clinical research study is to learn if Adcetris (brentuximab vedotin) can help to control mesothelioma. The safety of this drug will also be studied.

This is an investigational study. Brentuximab vedotin is FDA approved and commercially available for the treatment of Hodgkin lymphoma and anaplastic large cell lymphoma. It is considered investigational to use brentuximab vedotin in patients with mesothelioma. The study doctor can explain how the study drug is designed to work.

Up to 50 participants will be enrolled in this study. All will take part at MD Anderson.


Condition or disease Intervention/treatment Phase
Lung Diseases Due to External Agents Mesothelioma Drug: Brentuximab Vedotin Phase 2

Detailed Description:

Study Drug Administration:

There are 21 days (about 3 weeks) in each study cycle.

If you are found to be eligible to take part in this study, you will receive brentuximab vedotin by vein over about 30 minutes on Day 1 of every cycle.

Length of Study:

You may continue taking the study drug for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation on this study will be over after you have completed follow-up (described below).

Study Visits:

On Day 1 of every cycle:

  • You will have a physical exam
  • Blood (about 4 teaspoons) will be drawn for routine tests

Every 6 weeks while you are on study, you will have a PET-CT scan to check the status of the disease.

Follow-Up:

The study doctor or study team will follow you up with you about 30 days after your last dose of brentuximab vedotin by either reviewing your medical record or calling you to learn if you have had any side effects.

You will continue to have these follow-ups at 3 months, 6 months, and then every 6 months after that while you are on study.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Adcetris (Brentuximab Vedotin) in CD30+ Malignant Mesothelioma
Actual Study Start Date : April 5, 2017
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

Arm Intervention/treatment
Experimental: Brentuximab Vedotin

Participants receive Brentuximab Vedotin by vein on Day 1 of every 21 Day cycle.

Participants remain on trial until unacceptable toxicity, withdrawal of consent, or disease progression.

Drug: Brentuximab Vedotin

Starting Dose: 2.4 mg/kg by vein over 30 minutes on Day 1 of each 21 Day cycle.

Brentuximab vedotin capped at a maximum dose of 240 mg.

Other Names:
  • SGN-35
  • Adcetris




Primary Outcome Measures :
  1. Disease Control Rate (DCR) in Pre-Treated Participants with Unresectable Malignant Pleural Mesothelioma (MPM) Treated with Brentuximab Vedotin [ Time Frame: 4 months ]
    Disease control rate (DCR) defined as proportion of patients who had complete response, partial response or stable disease by RESIST 4.1.


Secondary Outcome Measures :
  1. Time to Progression in Pre-Treated Participants with Unresectable Malignant Pleural Mesothelioma (MPM) Treated with Brentuximab Vedotin [ Time Frame: 6 weeks ]

    Time to progression assessed by RESIST 4.1.

    Time to progression estimated using the method of Kaplan and Meier.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. 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 (ie, 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.
  3. Male subject, even if surgically sterilized (ie, 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.
  4. Absolute neutrophil count (ANC) > 1500/mm³, platelets > 100,000/mm³, Hgb > 8.5 g/dL.
  5. Total bilirubin </= 1.5 x upper limit of normal (ULN), SGOT (AST) and SGPT (ALT) < 3 x ULN. AST and/or ALT may be up to 5X ULN if with known liver mets
  6. Adequate renal function as defined by: Calculated creatinine clearance must be >/= 30 mL/minute
  7. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  8. Pathologic diagnosis of malignant mesothelioma (any primary site is acceptable, any histology is acceptable)
  9. Have unresectable malignant mesothelioma (any histology)
  10. Positive CD30+ immunohistochemical expression
  11. Any line of prior therapy - patients may be chemo-naïve or chemo-refractory (any line)
  12. Patients must have measurable disease by modified RECIST or RECIST. Examinations for assessment of measurable disease must have been completed within 28 days prior to registration.
  13. Patient must be >/= 18 years of age

Exclusion Criteria:

  1. Radiation therapy to more than 25% of the bone marrow. Whole pelvic radiation is considered to be over 25%.
  2. Prior allogeneic bone marrow or organ transplantation
  3. 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.
  4. Patient has received other investigational drugs with 14 days before enrollment
  5. Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
  6. 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.
  7. Known hypersensitivity to brentuximab vedotin components
  8. Persons who are incarcerated at time of enrollment (e.g., prisoners) or likely to become incarcerated during the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03007030


Contacts
Contact: Anne S. Tsao, MD 713-792-6363 astsao@mdanderson.org

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact       astsao@mdanderson.org   
Sponsors and Collaborators
M.D. Anderson Cancer Center
Seattle Genetics, Inc.
Investigators
Principal Investigator: Anne S. Tsao, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03007030     History of Changes
Other Study ID Numbers: 2016-0514
NCI-2017-00069 ( Registry Identifier: NCI CTRP )
First Posted: December 30, 2016    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Lung Diseases Due to External Agents
Mesothelioma
Unresectable malignant pleural mesothelioma
MPM
CD30+
Brentuximab vedotin
SGN-35
Adcetris

Additional relevant MeSH terms:
Mesothelioma
Lung Diseases
Respiratory Tract Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs