Clinical Trials /

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

NCT03007030

Description:

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.

Related Conditions:
  • Malignant Mesothelioma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Trial of Adcetris in CD30+ Malignant Mesothelioma
  • Official Title: Phase II Trial of Adcetris (Brentuximab Vedotin) in CD30+ Malignant Mesothelioma

Clinical Trial IDs

  • ORG STUDY ID: 2016-0514
  • SECONDARY ID: NCI-2017-00069
  • NCT ID: NCT03007030

Conditions

  • Lung Diseases Due to External Agents
  • Mesothelioma

Interventions

DrugSynonymsArms
Brentuximab VedotinSGN-35, AdcetrisBrentuximab Vedotin

Purpose

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.

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.

      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.
    

Trial Arms

NameTypeDescriptionInterventions
Brentuximab VedotinExperimentalParticipants 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.
  • Brentuximab Vedotin

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Disease Control Rate (DCR) in Pre-Treated Participants with Unresectable Malignant Pleural Mesothelioma (MPM) Treated with Brentuximab Vedotin
Time Frame:4 months
Safety Issue:
Description: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

Measure:Time to Progression in Pre-Treated Participants with Unresectable Malignant Pleural Mesothelioma (MPM) Treated with Brentuximab Vedotin
Time Frame:6 weeks
Safety Issue:
Description:Time to progression assessed by RESIST 4.1. Time to progression estimated using the method of Kaplan and Meier.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:M.D. Anderson Cancer Center

Trial Keywords

  • Lung Diseases Due to External Agents
  • Mesothelioma
  • Unresectable malignant pleural mesothelioma
  • MPM
  • CD30+
  • Brentuximab vedotin
  • SGN-35
  • Adcetris

Last Updated

September 11, 2017