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Clinical Trials (PDQ®)

Phase 2 Study of Inhaled Lipid Cisplatin in Pulmonary Recurrent Osteosarcoma

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIPreventionActive13 and overPharmaceutical / IndustryEP-ILC-201
NCT01650090

Trial Description

Summary

To establish whether treatment with Inhaled Lipid Cisplatin (ILC) is effective in delaying/preventing pulmonary relapse in osteosarcoma patients in complete surgical remission following one or two prior pulmonary relapses.

Further Study Information

ILC is a novel formulation of cisplatin, designed for inhalation by nebulization. The anticipated pulmonary benefits of ILC over systemic cisplatin therapy are threefold:

  • Increased local cisplatin concentrations
  • Sustained release of cisplatin in the lungs
  • Minimal systemic exposure to cisplatin

In this study, patients currently in surgical complete remission (CR) following one or two prior relapses of osteosarcoma involving pulmonary disease will be treated with ILC every two weeks for up to one year. ILC will be administered via nebulization.

Eligibility Criteria

Inclusion Criteria:

1. History of osteosarcoma metastatic to the lung(s). (First or second pulmonary recurrence(s) removed by surgery, and previous second-line systemic chemotherapy is allowed).

2. Patients must be macroscopically disease free following pulmonary metastectomy of a single or multiple lesions. Complete remission surgically (free of macroscopic disease) is required. Pleural disruption and/or microscopic positive margins are allowed.

3. Age ≥13 years.

4. Patients must have recovered sufficiently from all acute adverse effects of prior therapies, excluding alopecia.

5. Patients must have an ECOG performance status of 0-2. (Lansky score of 50-100 if < 16 years old).

6. Patients must have recovered sufficiently from surgery and have adequate airflow and pulmonary reserve. This decision should be at the investigator's discretion taking into consideration pre-surgery pulmonary function. (As a guideline: adequate airflow defined by a measured Forced Expiratory Volume (FEV1) not less than 50% of the predicted value and adequate pulmonary reserve as evidenced by a FEV1/FVC ratio of 65% or greater).

7. Patients must have adequate renal function as defined by a serum creatinine of ≤ 1.5 mg/dl.

8. Patients must have adequate liver function as defined by total bilirubin of ≤ 1.5 mg/dl and ALT or AST < 2.5 times the institution's upper normal limit.

9. Patients must have adequate bone marrow function as defined by an absolute neutrophil count (ANC) of ≥ 1,000/mm3 and platelet count of ≥ 100,000/mm3.

10. Signed informed consent including, where applicable, the consent of the patient's legal guardian.

Exclusion Criteria:

1. Current extrapulmonary disease.

2. Current macroscopic pulmonary lesions.

3. Greater than 2 pulmonary recurrences.

4. Greater than 4 weeks since thoracotomy rendering patient free of macroscopic disease.

5. Females who are pregnant or breast-feeding.

6. Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the patient in this study.

7. Contraindication to or unwillingness to undergo multiple CT scans and chest X-rays.

8. Unwillingness or inability to comply with the study protocol for any other reason.

9. Participation in an investigational drug or device study or treatment with any anti-neoplastic agent within 14 days of the first day of dosing on this study

Trial Contact Information

Trial Lead Organizations/Sponsors

Eleison Pharmaceuticals LLC

Richard GorlickPrincipal Investigator

Forrest H Anthony, MD, PhDStudy Director

Eleison PharmaceuticalsPh: 215-554-3530
  Email: info@eleison-pharma.com

Trial Sites

U.S.A.
California
  Los Angeles
 Children's Hospital Los Angeles
 Henry Yepez Ph: 323-361-5881
  Email: hmyepez@chla.usc.edu
 Lakshmi Damerla Ph: 323.361.8359
  Email: ldamerla@chla.usc.edu
 Leo MascarenhasPrincipal Investigator
 Rajkumar VenkatramaniSub-Investigator
  Palo Alto
 Stanford Cancer Center
 Christin New Ph: 650-497-8815
  Email: newc@stanford.edu
 Neyessa MarinaPrincipal Investigator
 Sheri L SpuntSub-Investigator
Florida
  Tampa
 H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
 Damon Reed, MD Ph: 813-745-4292
  Email: Damon.Reed@moffitt.org
 Courtney Yates, RN Ph: (813) 745-4292
  Email: Courtney.Yates@moffitt.org
 Damon Reed, MDPrincipal Investigator
 Mihaela DrutaSub-Investigator
Illinois
  Chicago
 University of Chicago Cancer Research Center
 Navin Pinto, MD Ph: 773-702-6808
  Email: npinto1@peds.bsd.uchicago.edu
 Navin Pinto, MDPrincipal Investigator
 Susan L CohnSub-Investigator
Louisiana
  New Orleans
 Ochsner Cancer Institute at Ochsner Clinic Foundation
 Robert J. Vasquez, MD, PhD. Ph: 504-842-5230
 Robert J. Vasquez, MD, PhD.Principal Investigator
 Gregory N SossamanSub-Investigator
Massachusetts
  Boston
 Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
 Suzanne Shusterman, MD Ph: 617-632-4901
  Email: Suzanne_Shusterman@dfci.harvard.edu
 Erin Parker Ph: 617-632-5222
  Email: ErinP_Parker@dfci.harvard.edu
 Suzanne Shusterman, MDPrincipal Investigator
 Annette M WergerSub-Investigator
Minnesota
  Rochester
 Mayo Clinic Cancer Center
 Clinical Trials Referral Office Ph: 507-538-7623
 Carola Arndt, MDPrincipal Investigator
 Stephen R AlbertsSub-Investigator
Missouri
  St. Louis
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 Aidan Combs Ph: 314-747-8368
  Email: acombs@DOM.wustl.edu
 Cheryl Callahan Ph: 314-286-2584
  Email: ccallaha@dom.wustl.edu
 Brian A Van Tine, MD, PhDPrincipal Investigator
 Douglas R AdkinsSub-Investigator
New York
  New York
 Memorial Sloan-Kettering Cancer Center
 Alex Chou, MD Ph: 212-639-6057
  Email: choua@mskcc.org
 Judy Persaud-Moore, MPH Ph: 646-888-5722
  Email: persauj1@mskcc.org
 Alexander J. ChouPrincipal Investigator
 Paul A. MeyersSub-Investigator
  The Bronx
 Albert Einstein Cancer Center at Albert Einstein College of Medicine
 Richard Gorlick, MD Ph: 718-741-2342
  Email: rgorlick@montefiore.org
 Jonathan Gill, MD Ph: 718-741-2342
  Email: jgill@montefiore.org
 Richard GorlickPrincipal Investigator
 Jonathan Gill, MDSub-Investigator
Tennessee
  Nashville
 Vanderbilt-Ingram Cancer Center
 Leigh Witherspoon Ph: 615-936-1473
  Email: leigh.witherspoon@vanderbilt.edu
 Vicki L KeedyPrincipal Investigator
 Scott C BorinsteinSub-Investigator
Texas
  Dallas
 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
 Ted Laetsch, MD Ph: 214-456-6405
  Email: Ted.Leatsch@UTSouthwestern.edu
 Alison Patterson Ph: 214-456-2726
  Email: alison.patterson@childrens.com
 Patrick Leavey, MDPrincipal Investigator
  Houston
 Baylor College of Medicine/Texas Children's Hospital
 Matteo Trucco, MD Ph: 832-824-4260
  Email: trucco@bcm.edu
 Brittany Pena Ph: 832-824-1514
  Email: brpena@txch.org
 Matteo Trucco, MDPrincipal Investigator
 Ricardo FloresSub-Investigator
Utah
  Salt Lake City
 Primary Children's Medical Center
 Salman Yakub Ph: 801-213-3765
  Email: Salman.Yakub@hsc.utah.edu
 Clinic Number Ph: 801-662-4700
 Jennifer Wright, MDPrincipal Investigator
 Holly Spraker-PerlmanSub-Investigator
Washington
  Seattle
 Children's Hospital and Regional Medical Center - Seattle
 Damon Jacobson Ph: 206-884-7851
  Email: damon.jacobson@seattlechildrens.org
 Doug Hawkins, MD Ph: 206 987-3096
  Email: doug.hawkins@seattlechildrens.org
 Douglas HawkinsPrincipal Investigator
 Rebecca JohnsonSub-Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01650090
ClinicalTrials.gov processed this data on September 04, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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