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Inhalation SLIT Cisplatin (Liposomal) for the Treatment of Osteosarcoma Metastatic to the Lung

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Insmed Incorporated
ClinicalTrials.gov Identifier:
NCT00102531
First received: January 29, 2005
Last updated: July 5, 2017
Last verified: July 2017
  Purpose
Phase Ib/IIa open label safety and efficacy study designed to determine the maximum tolerated dose of inhaled cisplatin liposomal (SLIT cisplatin) administered every 14 days to patients with relapsed/progressive osteosarcoma metastatic to the lung.

Condition Intervention Phase
Osteosarcoma Metastatic Drug: Cisplatin liposomal Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase Ib/IIa Study of SLIT Cisplatin by Inhalation in the Treatment of Patients Wtih Relapsed/Progressive Osteosarcoma Metastatic to the Lung

Resource links provided by NLM:


Further study details as provided by Insmed Incorporated:

Primary Outcome Measures:
  • The Study Medication Was to be Considered Effective if the Population Response Rate Was Found to be Greater Than 20% and Individuals Who Demonstrated a CR or PR or Whose Tumours Demonstrated a Grade 3 or 4 Histologic Response at the Time of Surgery. [ Time Frame: 4 to 48 weeks ]

Enrollment: 19
Actual Study Start Date: January 12, 2005
Study Completion Date: March 17, 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cisplatin liposomal 24 mg/m2
Inhaled liposomal cisplatin was administered over 1 day in a 14-day treatment cycle by inhalation for a maximum of 6 cycles.
Drug: Cisplatin liposomal
Other Name: SLIT Cisplatin
Experimental: Cisplatin liposomal 36 mg/m2
The study allowed for a dose escalation of liposomal cisplatin to 36 mg/m2 if no adverse events of Grade 3 or higher occurred after at least 3 cycles of drug administration at 24 mg/m2
Drug: Cisplatin liposomal
Other Name: SLIT Cisplatin

  Eligibility

Ages Eligible for Study:   13 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven, Progressive or recurrent high grade osteosarcoma metastatic to the lung
  • Patients with histologically proven, fully malignant high-grade osteosarcoma of bone
  • Measureable pulmonary metastases
  • Less than grade 3 neuropathies, insignificant decreases in cardiac or auditory function
  • ECOG performance status of 0, 1 or 2
  • FEV1 of 50% or greater of predicted value
  • FEV1/FVC ratio of 65% or greater
  • Serum creatinine of ≤ 1.5 mg/dl
  • Total bilirubin ≤ 1.5mg/dl and SGOT or SGPT < 2.5 times upper normal limit
  • ANC of ≥ 1,000/mm3 and platelet count of ≥ 100,000/mm3

Exclusion Criteria:

  • Grade 3 or higher painful neuropathy persisting after a prior platinum containing regimen
  • Patients who are pregnant or are of childbearing potential and not using methods to avoid pregnancy
  • Concurrent systemic chemotherapy
  • Greater than Grade 2 pulmonary toxicity
  • Pulmonary atelectasis
  • Reactive airway disease which has resulted in hospitalization within the last year or which requires daily treatment with bronchodilator therapy
  • Concurrent serious infections
  • Unstable or serious concurrent medical condition
  • Recent major surgery or thoracic radiation therapy or chemotherapy
  • Significant pulmonary fibrosis secondary to prior radiation
  • Major ventilatory distribution abnormalities
  • Osteosarcoma secondary to radiation or premalignant conditions
  • History of prior malignancy
  • Low grade osteosarcoma, parosteal or periosteal sarcoma
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00102531

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
The Albert Einstein College of Medicine Montefiore Medical Center
New York, New York, United States, 10467
Sponsors and Collaborators
Insmed Incorporated
Investigators
Study Chair: Renu Gupta, MD Transave Inc.
Principal Investigator: Richard Gorlick, MD The Albert Einstein College of Medicine Montefiore Medical Center
  More Information

Additional Information:
Publications:
Responsible Party: Insmed Incorporated
ClinicalTrials.gov Identifier: NCT00102531     History of Changes
Other Study ID Numbers: TR02-2421
Study First Received: January 29, 2005
Results First Received: July 5, 2017
Last Updated: July 5, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Insmed Incorporated:
Osteosarcoma
relapsed
progressive
metastatic
lung

Additional relevant MeSH terms:
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Cisplatin
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 18, 2017