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A Study Of Ranpirnase(Onconase®) To Pemetrexed Plus Carboplatin In Patients With Non-Squamous Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT01184287
Recruitment Status : Withdrawn (Program discontinued)
First Posted : August 18, 2010
Last Update Posted : September 2, 2015
Sponsor:
Information provided by:
Tamir Biotechnology, Inc.

Study Description
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Brief Summary:
The purpose of the trial is to determine the rate of improvement in objective tumor response, following the addition of ranpirnase to ongoing pemetrexed-carboplatin chemotherapy, for patients with SD or PR following 2 cycles of doublet chemotherapy.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Ranpirnase Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Addition of Ranpirnase(ONCONASE®) to Permetrexed Plus Carboplatin in Patientes With Non-Squamous Non-Small Cell Lung Cancer

Resource links provided by the National Library of Medicine

Drug Information available for: Carboplatin

Arms and Interventions
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Arm Intervention/treatment
Experimental: ranpirnase
All patients who do not progress after two cycles of pemetrexed-carboplatin will receive the study drug, ranpirnase
 Drug: Ranpirnase
Cycles 3 and until patient progression, on days 1,8 and 15 in a 21 day cycle
Other Name: Onconase


Outcome Measures
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Primary Outcome Measures :
  1. Response [ Time Frame: 4 or more months ]
    To determine the rate of improvement in objective tumor response, following the addition of ranpirnase to ongoing pemetrexed-carboplatin chemotherapy, for patients with SD or PR following 2 cycles of doublet chemotherapy


Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: 2 years ]
    To determine the PFS in patients with SD, PR or CR following 2 cycles of doublet chemotherapy

  2. Survival [ Time Frame: 2 years ]
    To determine the survival of patients with SD, PR or CR following 2 cycles of doublet chemotherapy


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age greater than 18 years
  • ECOG less than 2
  • Estimated survival of greater than 12 weeks

Exclusion Criteria:

  • Prior systemic chemotherapy for locally advanced or metastatic NSCLC
  • Use of any investigational agent within 28 days prior to registration
  • Known hypersensitivity to any of the study drugs
  • Brain metastases or leptomeningeal disease
  • History of prior malignancy within the past three years
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01184287


Locations
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United States, California
Tower Cancer Research Foundation
Beverly Hills, California, United States, 90211
United States, Michigan
Van Andel Research Institute
Grand Rapids, Michigan, United States, 49503
United States, Montana
Sletten Cancer Specialists
Great Falls, Montana, United States, 59405
United States, New York
The Cancer Institute at NYU Langone Medical Center
New York, New York, United States, 10016
United States, Ohio
Tri-county Hematology-Oncology Associates, Inc
Canton, Ohio, United States, 44718
United States, Utah
Northern Utah Associates
Ogden, Utah, United States, 84403
Sponsors and Collaborators
Tamir Biotechnology, Inc.
More Information
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Responsible Party: Charles Muniz, Tamir Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT01184287    
Other Study ID Numbers: P30-800
First Posted: August 18, 2010    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: August 2015
Keywords provided by Tamir Biotechnology, Inc.:
Non Small Cell Lung Cancer, NSCLC, Lung Cancer
Previously untreated Non-Squamous, Non-Small Cell Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Carcinoma, Bronchogenic
Bronchial Neoplasms
Ranpirnase
Antineoplastic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action