Depsipeptide/Flavopiridol Infusion for Cancers of the Lungs, Esophagus, Pleura, Thymus or Mediastinum

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Brief Title

Depsipeptide/Flavopiridol Infusion for Cancers of the Lungs, Esophagus, Pleura, Thymus or Mediastinum

Official Title

Phase I Study of Sequential Depsipeptide/Flavopiridol Infusion for Malignancies Involving Lungs, Esophagus, Pleura, Thymus or Mediastinum

Brief Summary

      This study will test the safety and effectiveness of two experimental medicines -
      depsipeptide and flavopiridol - given together to treat cancers of the lung, esophagus, and
      pleura. It will determine the highest dose that these drugs can safely be given together and
      will test whether giving them together works better at shrinking tumors than giving either
      one alone.

      Patients 18 years of age and older with cancer of the lung, esophagus, or pleura, or other
      cancers that have spread to the lungs or pleura may be eligible for this study. Candidates
      are screened with a medical history and physical examination, blood tests, electrocardiogram
      (EKG), x-rays and scans, pulmonary function tests, and a tumor biopsy (removal of a small
      piece of tumor tissue for microscopic examination).

      Participants are admitted to the hospital for treatment for approximately 10 days during each
      28-day treatment cycle. Depsipeptide is infused through an arm vein or central venous
      catheter (tube placed in a large vein in the neck or chest) for 4 hours. When this infusion
      is complete, flavopiridol is infused over 72 hours. The dose of depsipeptide is increased
      four times over the period of the study with successive groups of patients, and flavopiridol
      is increased once to determine the maximum safe dose of giving these drugs together.

      Blood tests are done before and after each depsipeptide infusion and 3 more times for the
      next 24 hours, and at various times over 4 days during the flavopiridol infusion to evaluate
      the effects of the medicines. Samples are also drawn periodically throughout the treatment
      cycle to evaluate safety. Heart function is monitored with several EKGs before and during the
      depsipeptide doses. The drug has shown effects on EKG tracings, but does not appear to injure
      the heart muscle.

      Tumor biopsies are done before treatment begins and on the fifth day of the first treatment
      cycle. The biopsies may be done either in the operating room by passing a tube (bronchoscope)
      down the throat and into the lungs or in the Radiology Department using a thin needle put
      through the chest wall into the tumor. For the bronchoscopy, numbing medicine is sprayed into
      the back of the throat to reduce discomfort, and for the needle biopsy, the skin over the
      biopsy area is numbed. Optional repeat biopsies may be requested before the start of the
      second treatment cycle and on day 5 of that cycle. (The repeat biopsies are not required for
      participation in the study.) At the time of each tumor biopsy, a buccal mucosal biopsy is
      also done. This involves scraping a tongue depressor along the inside of the mouth to collect
      cells for examination.

      At the end of the first treatment cycle, patients return to NIH for evaluation with a
      physical examination, blood work, x-rays, and scans of the chest, abdomen, pelvis, and brain.
      Patients who are not experiencing significant drug side effects are offered a second cycle,
      exactly like the first. The two cycles complete one course of treatment, after which patients
      once again return to NIH for evaluation. Additional treatment cycles may be offered to
      patients whose tumors have shrunk or remained stable with therapy. Patients whose tumors have
      not responded to therapy or who have developed severe drug side effects are taken off the
      study.
    

Detailed Description

      Background:

      In preclinical studies we have demonstrated that the histone deacetylase (HDAC) inhibitor
      Depsipeptide FR901228 (DP) mediates cell cycle arrest and apoptosis in cultured lung and
      esophageal cancer, and malignant pleural mesothelioma cells.

      We have observed that the cdk inhibitor Flavopiridol (FLA) markedly potentiates
      Depsipeptide-mediated apoptosis in cultured cancer cells, but not cultured normal epithelial
      cells.

      Patients with advanced malignancies involving lungs, esophagus, or pleura will receive 4-hour
      Depsipeptide infusion followed by 72-hour FLA infusion using a phase I study design.

      Tumor and buccal mucosa biopsies as well as PBMC may be obtained prior to, and after therapy
      to evaluate gene expression using cDNA array long-oligo and protein lysate array techniques,
      and determine if sequential DP/FLA mediates apoptosis in target tissues.

      Results of these studies may provide the rationale for phase II evaluation of sequential
      DP/FLA infusion in thoracic oncology patients.

      Objectives:

      Primary objectives:

      To define the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of sequential 4
      hour Depsipeptide(DP)/72 hour Flavopiridol (FLA)

      To evaluate the pharmacokinetics of sequential DP/FLA infusion

      Secondary objectives

      To analyze gene expression profiles in laser-captured tumor cells, buccal mucosa, and PBMC
      before and after sequential DP/FLA exposure.

      To analyze mcl-1 protein expression and apoptosis in tumor biopsies before and after
      sequential DP/FLA treatment.

      Tertiary objectives:

      The development of tissue and serum proteomic techniques to assess treatment response in
      patients receiving sequential DP/FLA infusions.

      Eligibility:

      Patients with histologically or cytologically proven primary small cell or non-small cell
      lung cancers, esophageal cancers, malignant pleural mesotheliomas or chest wall sarcoma, or
      thymomas are eligible for evaluation. In addition, patients with cancers of nonthoracic
      origin with metastases to the lungs or pleura, or germ cell tumors refractory to standard
      therapy are eligible for evaluation.

      Patients must have an ECOG performance status of 0 - 2.

      Patients must have adequate pulmonary reserve evidenced by FEV1 and DLCO greater than the 30
      percent predicted, and pCO2 less than 50 mm Hg and pO2 greater than 60 mm Hg on room air ABG.

      Patients must be 18 years of age or older.

      Adequate organ function as evidenced by standard laboratory parameters.

      The patient must be willing to sign an informed consent.

      Design:

      A phase 1 study where patient cohorts will receive escalating doses of Depsipeptide,
      administered on day 1 and day 21, and a dose of flavopiridol (either 40 mg/m2/d or 50
      mg/m2/d) administered on days 1-3, and 21-24 of a 42-day course.

      Pharmacokinetics, systemic toxicity, and response to therapy will be recorded.

      Two cycles of therapy (one course) will be administered, following which treatment evaluation
      will be performed using standard clinical criteria.

      48 patients will be enrolled over a period of 2-4 years.
    

Study Phase

Phase 1

Study Type

Interventional




Condition

Carcinoma, Small Cell

Intervention

Depsipeptide


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

23

Start Date

October 25, 2004

Completion Date

May 20, 2013

Primary Completion Date

May 20, 2013

Eligibility Criteria

        -  INCLUSION CRITERIA:

               1. Patients with histologically or cytologically proven small cell or non-small cell
                  lung cancers, esophageal cancers, malignant pleural mesotheliomas chest wall
                  sarcoma, or epithelial thymomas are eligible for evaluation. In addition,
                  patients with cancers of nonthoracic origin with metastases to the lungs, pleura
                  or germ cell tumors refractory to standard therapy are eligible for evaluation.

               2. Chemo naive patients with inoperable lung and esophageal cancers, pleural
                  mesotheliomas, sarcoma, thymomas, as well as tumors of non-thoracic origin with
                  metastasis within the thorax may be eligible for study provided they have been
                  apprised of, and refused potentially effective first line chemotherapy.

               3. Patients with intracranial metastases which have been treated by surgery or
                  radiation therapy may be eligible for study provided there is no evidence of
                  active disease and no requirement for anticonvulsant therapy or steroids.

               4. Patients with prior Depsipeptide or Flavopiridol exposure are eligible for study
                  provided they have not experienced dose limiting toxicity at the dose of DP or
                  FLA that they are scheduled to receive.

               5. Patients must have had no chemotherapy, biologic therapy, or radiation therapy
                  for their malignancy for at least 30 days prior to treatment. At least six weeks
                  must elapse between mitomycin C or nitrosourea treatment and DP/FLA therapy.
                  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.

               6. Patients must have an ECOG performance status of 0 - 2.

               7. Patients must have adequate pulmonary reserve evidenced by FEV1 and DLCO greater
                  than the 30% predicted, and pCO2 less than 50 mm Hg and pO2 greater than 60 mm Hg
                  on room air ABG.

               8. Patients must be 18 years of age or older due to the unknown effects of HDAC
                  inhibitors and cdk inhibitors during childhood and adolescent development.

               9. Patients must have a platelet count greater than 100,000, an ANC equal to or
                  greater than 1500 without transfusion or cytokine support, a normal PT, and
                  adequate hepatic function as evidenced by a total bilirubin of less than 1.5 x
                  upper limits of normal, and AST/ALT less than or equal to 1.5 times upper limit
                  of normal. Serum creatinine less than or equal to 1.6 mg/ml or the creatinine
                  clearance must be greater than 70 ml/min/1.73m(2).

              10. Patients must be aware of the neoplastic nature of his/her illness, the
                  experimental nature of the therapy, alternative treatments, potential benefits,
                  and risks. The patient must be willing to sign an informed consent.

        EXCLUSION CRITERIA:

          1. Patients with limited stage SCLC and operable NSCLC or operable esophageal cancer will
             be excluded.

          2. Patients with potentially treatable pulmonary metastases from lymphomas or germ cell
             tumors will be excluded.

          3. Patients who have received three or more systemic cytotoxic treatment regimens will be
             excluded due to possible cumulative marrow suppression.

          4. Cardiac exclusion criteria, patients with known cardiac abnormalities such as:

             Uncontrolled arrhythmias

               -  History of serious ventricular arrhythmias not controlled by coronary artery
                  bypass surgery.

               -  Patients with a history of sustained VT, VF, Toursades de Pointes, or cardiac
                  arrest who do not have an automatic implantable cardioverter defibrillator in
                  place.

               -  Congenital Long QT syndrome or QTc greater than 480 msec.

               -  Patients with Mobitz II second degree block who do not have a pacemaker.

               -  Patients with any cardiac arrhythmia requiring anti-arrhythmic medication other
                  than a beta blocker or calcium channel blocker.

               -  Patients in whom digitalis cannot be discontinued.

             Decompensated heart failure (NYHA Class II or IV).

             LVEF less than 50% by MUGA scan or echocardiogram.

             Hypertrophic or restrictive cardiomyopathy from prior treatment of other causes and
             patients with left ventricular hypertrophy.

             Uncontrolled hypertension (i.e. greater than or equal to160/95).

             Myocardial infarction within one year of study.

             Clinically significant active myocardial ischemia on the basis of nuclear imaging or
             angiography.

             History of coronary artery disease (e.g. angina Canadian Class II-IV or positive
             stress imaging study).

             Patients with other cardiac disease may be excluded at the discretion of the PI
             following consultation with cardiology.

          5. Co-medication causing QTc prolongation (information at Appendix A and
             http://georgetowncert.org/gqdrugs_torsades.asp) unless a 5 half-life washout period
             has elapsed between discontinuing the drug and entering this study.

          6. Patients with active intracranial and leptomeningeal metastases, as well as those
             requiring anticonvulsant medications or steroids to control cerebral edema will be
             excluded.

          7. Patients with life expectancy less than three months will be excluded.

          8. Patients with pulmonary embolism or deep venous thrombosis requiring anticoagulation
             within six months of protocol entry will be excluded.

          9. Pregnant patients and nursing mothers will be excluded due to the unknown, potentially
             harmful effects of HDAC inhibitors and cdk inhibitors on fetal and early childhood
             development.

         10. Patients with active infections will be excluded.

         11. Patients with HIV infection will be excluded due to the potential risk of
             opportunistic infection during DP/FLA-induced myelosuppression and potentially
             deleterious activation of viral gene expression.

         12. Patients will have a screening 12 lead EKG and those patients with left ventricular
             hypertrophy will not be eligible.

         13. Patients who are taking hydrochlorothiazide (HCTZ) will have this agent stopped or
             switched to a potassium-conserving combination (e.g. Maxide or Dyazide) or other
             antihypertensive agent. Patients, who cannot have the agent stopped or switched to a
             potassium-conserving combination or other antihypertensive agent, will not be
             eligible.
      

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

NCT00094978

Organization ID

050010

Secondary IDs

05-C-0010


Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

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


Verification Date

May 20, 2013