Cisplatin, Pemetrexed, and Imatinib Mesylate in Malignant Mesothelioma

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Pleurectomy/Decortication (Neo) Adjuvant Chemotherapy and Intensity Modulated Radiation Therapy to the Pleura in Patients With Locally Advanced Malignant Pleural Mesothelioma Pembrolizumab and Hypofractionated Stereotactic Radiotherapy in Patients With Malignant Pleural Mesothelioma Study of CBP501 + Pemetrexed + Cisplatin on MPM (Phase I/II) NGR015: Study in Second Line for Patient With Advanced Malignant Pleural Mesothelioma Pretreated With Pemetrexed Dendritic Cell-based Immunotherapy in Mesothelioma MTG201 Plus Nivolumab in Patients With Relapsed Pleural Mesothelioma Nintedanib in Treating Patients With Malignant Pleural Mesothelioma That Is Recurrent Active Symptom Control With or Without Chemotherapy in Treating Patients With Malignant Pleural Mesothelioma Do Your Genes Put You at a Higher Risk of Developing Mesothelioma Trimodality Therapy for Malignant Pleural Mesothelioma Pleurectomy/Decortication Followed by Intrathoracic/Intraperitoneal Heated Cisplatin for Malignant Pleural Mesothelioma Intracavitary Cisplatin-Fibrin Localized Chemotherapy After P/D or EPP for Malignant Pleural Mesothelioma Ganetespib With Platinum, in Patients With Malignant Pleural Mesothelioma Efficacy & Safety of rAd-IFN Administered With Celecoxib & Gemcitabine in Patients With Malignant Pleural Mesothelioma A Phase 2 Study of Durvalumab in Combination With Tremelimumab in Malignant Pleural Mesothelioma Prospectively Collected Pleural Biopsies for Validation of Malignant Pleural Mesothelioma Prognostic Biomarkers Phase II Study of Six Hours Low Dose Gemcitabine Plus Cisplatin in the Treatment for Advanced Pleural Mesothelioma Safety and Efficacy of Listeria in Combination With Chemotherapy as Front-line Treatment for Malignant Pleural Mesothelioma Intrapleural Photodynamic Therapy in a Multimodal Treatment for Patients With Malignant Pleural Mesothelioma Re-directed T Cells for the Treatment (FAP)-Positive Malignant Pleural Mesothelioma Concurrent Pemetrexed/Cisplatin With Pleural Intensity Modulated Radiation Therapy for Patients With Unresectable Malignant Pleural Mesothelioma Study of Cytoreductive Surgery and Hyperthermic Intraoperative Chemotherapy With Pemetrexed and Cisplatin for Malignant Pleural Mesotheliomas Effect of FAS and FAS Ligand Polymorphisms on Patients With Platinum-Based -Treated Malignant Pleural Mesothelioma Dasatinib in Resectable Malignant Pleural Mesothelioma Palliative Treatment With Liposomal Doxorubicin Plus Cisplatin for Patients With Malignant Pleural Mesothelioma Effect of Expression of CD74 and VEGF on Outcome of Treatment in Patients With Malignant Pleural Mesothelioma Clinical Study of YS110 in Patients With Malignant Pleural Mesothelioma Lurbinectedin Monotherapy in Patients With Progressive Malignant Pleural Mesothelioma. 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Brief Title

Cisplatin, Pemetrexed, and Imatinib Mesylate in Malignant Mesothelioma

Official Title

Phase I Trial of Cisplatin, Pemetrexed, and Imatinib Mesylate in Unresectable or Metastatic Malignant Mesothelioma

Brief Summary

      Primary Objective:

        -  To determine the maximum tolerated dose of the combination of cisplatin, imatinib
           mesylate, and pemetrexed in metastatic malignant mesothelioma.

      Secondary Objectives:

        -  To explore the biologic effects of cisplatin, imatinib mesylate, and pemetrexed on tumor
           tissue by:

        -  histologic analysis of biopsy tissue

        -  by non-invasive assessments of tumor vascularity performed before, during and after
           treatment

        -  electron microscopy analysis of endothelial cell architecture after patient treatment
           with imatinib mesylate

        -  To explore the effects of cisplatin, imatinib mesylate, and pemetrexed on surrogate
           markers in serum.

        -  To assess the rate of response to therapy.

        -  To determine the doses of the combination regimen of cisplatin, imatinib mesylate, and
           pemetrexed that enables de-phosphorylation of platelet derived growth factor receptor
           (PDGF-R) on malignant mesothelioma tumor cells.

        -  To determine the pharmacokinetic interaction between agents in this combination regimen.
    

Detailed Description

      Cisplatin is used to treat different cancers, including testicular, germ cell, head and neck,
      bladder, and lung cancer. This drug has an atom-containing platinum, which is designed to
      poison cancer cells, causing them to die.

      Pemetrexed is designed to block enzymes in the body that play a part in tumor growth.

      Imatinib mesylate is a drug that blocks certain proteins that play a part in the development
      of cancer. Imatinib mesylate has also been shown to increase the effect of chemotherapy in
      tumor cells.

      Before you can start treatment on this study, you will have what are called "screening
      tests." These tests will help the doctor decide if you are eligible to take part in this
      study. You will have your complete medical history recorded and a physical exam, including
      measurement of your vital signs (temperature, pulse, breathing rate, and blood pressure) and
      weight. An ECOG performance status evaluation (a test looking at your ability to perform
      day-to-day activities) will be done. Blood will be drawn (about 3 to 4 teaspoons) through a
      needle in your vein for routine tests. You will be asked about any medications you are
      taking. Women who are able to have children must have a negative blood pregnancy test. Also,
      your tumor will be evaluated by magnetic resonance imaging (MRI) or computerized tomography
      (CT) scans before the start of this study.

      If you are found to be eligible to take part in this study, you will begin taking imatinib
      mesylate. Depending on when you begin treatment on this study, you may be asked to take 3, 4,
      or 6 tablets of imatinib mesylate by mouth once a day. Your doctor will also ask you to take
      folic acid tablets (or a multivitamin with folic acid) during the week before you receive
      your first infusion of pemetrexed and then every day while you are on this study. You will
      also be given an injection of vitamin B12. The vitamin B12 shot will be repeated every 9
      weeks during treatment on this study. Folic acid and vitamin B12 will help to decrease the
      risk of severe side effects from pemetrexed.

      After 1 week of imatinib mesylate and folic acid, you will receive cisplatin and pemetrexed
      by IV infusion. Cisplatin (given over 2 hours) and pemetrexed (given over 40 minutes) will be
      given on the first day of each treatment cycle for a total of 6 cycles. Each cycle is 28 days
      long.

      Dexamethasone will also be given by vein before you receive pemetrexed. Dexamethasone will
      help to decrease the risk of rash and nausea that may be caused by pemetrexed. Your doctor
      will also ask you to take dexamethasone tablets by mouth twice a day (12 hours apart) only on
      Day 2 of each cycle.

      Every 4 weeks, you will have a physical exam, including measurement of your vital signs and
      weight. You will also have a performance status evaluation. Blood will be drawn (about 3 to 4
      teaspoons) through a needle in your vein for routine tests. Also, at every 8 weeks, your
      tumor will be measured by a CT or an MRI scan.

      After you complete 6 treatment cycles of cisplatin and pemetrexed, you will continue to take
      imatinib mesylate tablets every day up to 1 month after the 6 treatment cycles. If you
      develop any intolerable side effects or if your disease gets worse, your treatment on this
      study may be delayed; the dose of the study drugs decreased until your side effects are gone;
      or you may be taken completely off this study. Your doctor will talk with you about any
      changes in your dosing schedule or in the doses of your medication after you been evaluated
      in the clinic.

      After you have completed all of your treatment, you will have what is called an end-of-study
      visit. At this visit, you will have a physical exam, including measurement of your vital
      signs and weight. You will have an ECOG performance status evaluation. You will have blood
      drawn (about 3 to 4 teaspoons) through a needed in your vein for routine tests. You will also
      have your tumor measured by CT or an MRI scan.

      This is an investigational study. Both cisplatin and pemetrexed have been approved by the FDA
      for the treatment of malignant mesothelioma. The FDA has approved imatinib mesylate for the
      treatment of leukemia and certain sarcomas; however, it has been authorized by the FDA for
      use in research only in the treatment of malignant mesothelioma. Up to 42 patients will take
      part in this study. All will be enrolled at M. D. Anderson.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Maximum Tolerated Dose (MTD) of Cisplatin, Pemetrexed, and Imatinib Mesylate Given to Participants with Unresectable or Metastatic Malignant Mesothelioma


Condition

Mesothelioma

Intervention

Cisplatin

Study Arms / Comparison Groups

 Cisplatin + Imatinib + Pemetrexed
Description:  Cisplatin 60 mg/m^2 by vein, Over 2 Hours. Imatinib 300 mg PO Daily. Pemetrexed 500 mg/m^2 by vein, Over 40 Minutes. Dexamethasone 20 mg by vein given prior to Pemetrexed therapy and 4 mg given orally on Day 2 of each cycle.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

19

Start Date

August 2006

Completion Date

February 2014

Primary Completion Date

February 2014

Eligibility Criteria

        Inclusion Criteria:

          1. A written, voluntary informed consent form must be completed prior to beginning any
             study procedure.

          2. Patients >/= 18 years of age.

          3. Histologically documented diagnosis of malignant mesothelioma.

          4. Performance status 0-2 (ECOG)

          5. Patients must have adequate hepatic,renal,& bone marrow function,defined as the
             following:(1) total bilirubin /= 1.5x10^9/L;(5) platelets>/=100 x 10^9/L.Note:Renal function is
             only based on serum creatinine level /= 45mg/dl.

          6. Female patients of childbearing potential must have negative pregnancy test within 7
             days before initiation of study drug dosing. Postmenopausal women must be amenorrheic
             for at least 12 months to be considered of non-childbearing potential. Male and female
             patients of reproductive potential must agree to employ an effective barrier method of
             birth control throughout the study and for up to 3 months following discontinuation of
             study drug.

          7. Patients who have not received prior chemotherapy for their metastatic or recurrent
             unresectable malignant mesothelioma; with the exception of patients who have recurrent
             mesothelioma after induction chemotherapy followed by definitive treatment (surgery
             +/- radiotherapy). Patients must have had 2 or fewer cycles/doses of induction
             chemotherapy and must have had tumor response to the induction therapy.

          8. Patients must have documented unresectable malignant mesothelioma (pleural or
             peritoneal).

          9. Patients with treated brain metastasis who have stable brain disease (i.e. no steroids
             at least 4 weeks prior to study enrollment).

        Exclusion Criteria:

          1. Patient has received any other investigational agents within 28 days of first day of
             study drug dosing.

          2. Patient is /= 25 % of the bone marrow.

         12. Patient had a major surgery within 2 weeks prior to study entry.

         13. Patient with any significant history of non-compliance to medical regimens or with
             inability to grant reliable informed consent.

         14. Patients must agree not to use herbal remedies or other over-the-counter biologics
             (i.e. shark cartilage).

         15. Prior exposure to imatinib mesylate.

         16. Patients taking therapeutic levels of warfarin. However, patients receiving 1 mg daily
             for catheter related anticoagulation are eligible for the study.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Anne S. Tsao, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00402766

Organization ID

2005-0288

Secondary IDs

NCI-2012-01381

Responsible Party

Sponsor

Study Sponsor

M.D. Anderson Cancer Center

Collaborators

 Novartis

Study Sponsor

Anne S. Tsao, MD, Principal Investigator, M.D. Anderson Cancer Center


Verification Date

November 2015