Mithramycin for Lung, Esophagus, and Other Chest Cancers

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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. Safety and Efficacy of TTFields (150 kHz) Concomitant With Pemetrexed and Cisplatin or Carboplatin in Malignant Pleural Mesothelioma (STELLAR) A Phase II Study of PF-03446962 in Patients With Advanced Malignant Pleural Mesothelioma Direct Injection of Poly-ICLC (Hiltonol®) Vaccine In Malignant Pleural Mesothelioma A Phase I/II Study of First Line Vorinostat With Pemetrexed-cisplatin, in Patients With Malignant Pleural Mesothelioma ATREUS – Phase II Study on the Activity of Trabectedin in Patients With Malignant Pleural Mesothelioma (MPM) Accelerated Hypofractionated Radiotherapy in the Treatment of Malignant Pleural Mesothelioma Pembrolizumab + Defactinib In Pleural Mesothelioma Window of Opportunity Study of VS-6063 (Defactinib) in Surgical Resectable Malignant Pleural Mesothelioma Participants A Study of Atezolizumab in Unresectable or Advaced Malignant Pleural Mesothelioma A Clinical Trial of ADI-PEG 20TM in Patients With Malignant Pleural Mesothelioma Study of NGR-hTNF as Single Agent in Patients Affected by Advanced or Metastatic Malignant Pleural Mesothelioma Extrapleural Pneumonectomy /Pleurectomy Decortication, IHOC Cisplatin and Gemcitabine With Amifostine and Sodium Thiosulfate Cytoprotection for Resectable Malignant Pleural Mesothelioma Transarterial Chemoperfusion: Cisplatin, Methotrexate, Gemcitabine for Unresectable Pleural Mesothelioma Study of Carboplatin and Vinorelbine in Malignant Pleural Mesothelioma Vascularity Impact on the Treatment Outcome in Malignant Pleural Mesothelioma(VITMPM) Safety Confirmation Study of Pemetrexed Plus Cisplatin in Patients With Malignant Pleural Mesothelioma Intrapleural Administration of HSV1716 to Treat Patients With Malignant Pleural Mesothelioma. Placebo Controlled Study of VS-6063 in Subjects With Malignant Pleural Mesothelioma Response Evaluation in Malignant Pleural Mesothelioma Gemcitabine in Long Infusion and Cisplatin for Malignant Pleural Mesothelioma Treatment

Brief Title

Mithramycin for Lung, Esophagus, and Other Chest Cancers

Official Title

Phase II Evaluation of Mithramycin, an Inhibitor of Cancer Stem Cell Signaling, in Patients With Malignancies Involving Lungs, Esophagus, Pleura, or Mediastinum

Brief Summary

      Background:

      - Mithramycin is a drug that was first tested as a cancer therapy in the 1960s. It acted
      against some forms of cancer, but was never accepted as a treatment. Research suggests that
      it may be useful against some cancers of the chest, such as lung and esophageal cancer or
      mesothelioma. Researchers want to see if mithramycin can be used to treat these types of
      cancer.

      Objectives:

      - To see if mithramycin is safe and effective against different chest cancers.

      Eligibility:

      - Individuals at least 18 years of age who have lung, esophagus, pleura, or mediastinum
      cancers.

      Design:

        -  Participants will be screened with a physical exam and medical history. Blood and urine
           samples will be collected. Imaging studies and tumor tissue samples will be used to
           monitor the cancer before treatment.

        -  Participants will receive mithramycin every day for 7 days, followed by 7 days without
           treatment. Each 14-day round of treatment is called a cycle.

        -  Treatment will be monitored with frequent blood tests and imaging studies.

        -  Participants will continue to take the drug for as long as the side effects are not
           severe and the tumor responds to treatment.
    

Detailed Description

      Background:

      Increasing evidence indicates that activation of stem cell gene expression is a common
      mechanism by which environmental carcinogens mediate initiation and progression of thoracic
      malignancies. Similar mechanisms appear to contribute to extra-thoracic malignancies that
      metastasize to the chest. Utilization of pharmacologic agents, which target gene regulatory
      networks mediating stemness may be novel strategies for treatment of these neoplasms. Recent
      studies performed in the Thoracic Epigenetics Laboratory, Thoracic and Oncology Surgery
      Branch (TOSB)/National Cancer Institute (NCI), demonstrate that under exposure conditions
      potentially achievable in clinical settings, mithramycin diminishes stem cell gene expression
      and markedly inhibits growth of lung and esophageal cancer and malignant pleural mesothelioma
      (MPM) cells in vitro and in vivo. These finding add to other recent preclinical studies
      demonstrating impressive anti-tumor activity of mithramycin in epithelial malignancies and
      sarcomas that frequently metastasize to the thorax.

      Primary Objective:

      -To assess clinical response rates of mithramycin administered as 6 hour intravenous
      infusions in patients with malignancies involving lungs, esophagus, pleura, or mediastinum.

      Eligibility:

        -  Patients with measurable inoperable, histologically confirmed primary lung and
           esophageal carcinomas, thymic neoplasms, germ cell tumors, malignant pleural
           mesotheliomas or chest wall sarcomas, as well as patients with gastric, colorectal or
           renal cancers and sarcomas metastatic to the thorax are eligible.

        -  Patients with germline single nucleotide polymorphisms (SNPs) in adenosine
           5-triphosphate binding cassette subfamily B member 4 (ABCB4), adenosine 5-triphosphate
           binding cassette subfamily B member 11 (ABCB11), retinal-binding protein (RALBP) or
           cytochrome P851 (CYP851) that are associated with resistance to mithramycin-induced
           hepatotoxicity.

        -  Patients must have had or refused first-line standard therapy for their malignancies.

        -  Patients must be 18 years or older with an Eastern Cooperative Oncology Group (ECOG)
           performance status of 0-2, without evidence of unstable or decompensated myocardial
           disease. Patients must have adequate pulmonary reserve evidenced by forced expiratory
           volume 1 (FEV1) and diffusing capacity for carbon monoxide (DLCO) equal to or greater
           than 30% predicted; oxygen saturation greater than or equal to 92% on room air. Arterial
           Blood Gas (ABG) will be drawn if clinically indicated.

        -  Patients must have a platelet count greater than 100,000, an absolute neutrophil count
           (ANC) equal to or greater than 1500 without transfusion or cytokine support, a normal
           prothrombin time (PT)/partial thromboplastin time (PTT), and adequate hepatic function
           as evidenced by a total bilirubin of <1.5 times upper limits of normal (ULN) and
           aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than or equal to 3
           x ULN. Serum creatinine less than 3 or equal to 1.6 mg/ml, or creatinine clearance
           greater than 70 ml/min/1.73m^2.

      Design:

        -  Simon Optimal Two Stage Design for Phase II Clinical Trials targeting an objective
           response rate (Response Evaluation Criteria in Solid Tumors (RECIST)) of 30%.

        -  Patients will be stratified based on location of primary disease (thoracic vs.
           extra-thoracic).

        -  Patients will receive 6 hour infusions of mithramycin at 30 -50 mcg/kg every day for 7
           days, every 21 days (1 cycle). Three cycles will constitute one course of therapy. Those
           patients tolerating 30 mcg/kg infusions during the first cycle will receive subsequent
           cycles of mithramycin at a dose of 50 mcg/kg using the same infusion schedule.

        -  Following each course of therapy, patients will undergo restaging studies. Patients
           exhibiting objective response to therapy or stable disease by RECIST criteria will be
           offered an additional course of therapy.

        -  Patients exhibiting disease progression will be removed from study.

        -  Biopsies of index lesions will be obtained at baseline and on day 8 of the second cycle
           of therapy for analysis of molecular end-points.

        -  Pharmacokinetics will be assessed during cycle 1 and cycle 2 of the first course of
           therapy.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Number of Participants With an Objective Response (Complete Response + Partial Response)

Secondary Outcome

 Number of Participants With Serious and Non-Serious Adverse Events

Condition

Lung Cancer

Intervention

Mithramycin

Study Arms / Comparison Groups

 1/mithramycin
Description:  Single agent intravenous (IV) mithramycin

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

16

Start Date

September 6, 2012

Completion Date

September 27, 2019

Primary Completion Date

August 20, 2019

Eligibility Criteria

        -  INCLUSION CRITERIA:

          -  Diagnosis: Patients with measurable inoperable, histologically confirmed primary lung
             and esophageal carcinomas, thymic neoplasms, germ cell tumors, malignant pleural
             mesotheliomas or chest wall sarcomas, as well as patients with gastric, colorectal or
             renal cancers and sarcomas metastatic to the thorax are eligible

          -  Histologic confirmation of disease in the Laboratory of Pathology, Center for Cancer
             Research (CCR), National Cancer Institute (NCI), National Institutes of Health (NIH).

          -  Disease amenable to biopsy via percutaneous approach or other minimally invasive
             procedures such as thoracoscopy, bronchoscopy, laparoscopy, or gastrointestinal (GI)
             endoscopy

          -  Age >18

          -  Eastern Cooperative Oncology Group (ECOG) status 0-2.

          -  Patients must have had or refused first-line standard chemotherapy for their
             inoperable malignancies.

          -  Patients must have had no chemotherapy, biologic therapy, or radiation therapy for
             their malignancy for at least 30 days prior to treatment. Patients may have received
             localized radiation therapy to non-target lesions provided that the radiotherapy is
             completed 14 days prior to commencing therapy, and the patient has recovered from any
             toxicity. At least 3 half-lives must have elapsed since monoclonal antibody treatment.
             At least six weeks must have elapsed between mitomycin C or nitrosourea treatment.

          -  Patients must have adequate organ and marrow function as defined below:

             a) Hematologic and Coagulation Parameters:

             i. Peripheral absolute neutrophil count (ANC) greater than or equal to 1500/mm^3

        ii. Platelets greater than or equal to 100,000/ mm^3 (transfusion independent)

        iii. Hemoglobin greater than or equal to 8 g/dL (peripheral red blood count (PRBC)
        transfusions permitted)

        iv. Prothrombin Time (PT)/Partial Thromboplastin Time (PTT) within normal limits (patient
        may be eligible for trial if abnormality is deemed clinically insignificant and cleared for
        protocol therapy by Hematology Consult Service)

        b) Hepatic Function

        i. Bilirubin (total) < 1.5 times upper limit of normal (ULN)

        ii. Alanine aminotransferase (ALT) (Serum glutamic pyruvic transaminase (SGPT)) less than
        or equal to 3.0 times ULN

        iii. Albumin > 2 g/dL

        c) Renal Function

        i. Creatinine within normal institutional limits or creatinine clearance greater than or
        equal to 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal.

        ii. Normal ionized calcium, magnesium and phosphorus (can be on oral supplementation)

          -  Cardiac Function: Left ventricular ejection fraction (EF) >40% by Echocardiogram,
             multi-gated acquisition scan (MUGA), or cardiac magnetic resonance (MR).

          -  Ability of subject to understand, and be willing to sign informed consent.

          -  Female and male patients (and when relevant their partners) must be willing to
             practice birth control (including abstinence) during and for two months after
             treatment, if of childbearing potential during sexual contact with a female of
             childbearing potential.

          -  Patients must be willing to undergo 2 tumor biopsies

        EXCLUSION CRITERIA:

          -  Patients with adenosine 5-triphosphate binding cassette subfamily B member 4 (ABCB4),
             adenosine 5-triphosphate binding cassette subfamily B member 11 (ABCB11),
             retinal-binding protein (RALBP) or cytochrome P851 (CYP851) genotypes associated with
             mithramycin-mediated hepatotoxicity.

          -  Clinically significant systemic illness (e.g. serious active infections or significant
             cardiac, pulmonary, hepatic or other organ dysfunction), that in the judgment of the
             Principal Investigator (PI) would compromise the patients ability to tolerate protocol
             therapy or significantly increase the risk of complications

          -  Patients with cerebral metastases

          -  Patients with any of the following pulmonary function abnormalities will be excluded:
             forced expiratory volume (FEV), < 30% predicted; diffusing capacity for carbon
             monoxide (DLCO), < 30% predicted (post-bronchodilator); Oxygen saturation greater than
             92% on room air. Arterial Blood Gas will be drawn if clinically indicated.

          -  Patients with evidence of active bleeding, intratumoral hemorrhage or history of
             bleeding diatheses, unless specifically occurring as an isolated incident during
             reversible chemotherapy induced thrombocytopenia

          -  Patients on therapeutic anticoagulation. Note: prophylactic anticoagulation (i.e.
             intraluminal heparin) for venous or arterial access devices is allowed

          -  Patients who are concurrently receiving or requiring any of the following agents,
             which may increase the risk for mithramycin related toxicities, such as hemorrhage:

               -  Thrombolytic agents

               -  Aspirin or salicylate-containing products, which may increase risk of hemorrhage

               -  Dextran

               -  Dipyridamole

               -  Sulfinpyrazone

               -  Valproic acid

               -  Clopidogrel

          -  Lactating or pregnant females (due to risk to fetus or newborn, and lack of testing
             for excretion in breast milk)

          -  Patients with history of Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV)
             or Hepatitis C Virus (HCV) due to potentially increased risk of mithramycin toxicity
             in this population

          -  Hypersensitivity to mithramycin

          -  Patients who in the opinion of the investigator may not be able to comply with the
             safety monitoring requirements of the study
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

David S Schrump, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01624090

Organization ID

120151

Secondary IDs

12-C-0151

Responsible Party

Principal Investigator

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

David S Schrump, M.D., Principal Investigator, National Cancer Institute (NCI)


Verification Date

December 2019