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Prospective Trial of Rituximab for Primary Pulmonary Alveolar Proteinosis (PAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00552461
Recruitment Status : Unknown
Verified May 2008 by East Carolina University.
Recruitment status was:  Recruiting
First Posted : November 2, 2007
Last Update Posted : May 9, 2008
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by:
East Carolina University

Study Description
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Brief Summary:
The purpose of this study is to determine whether the use of rituximab is effective in treating pulmonary alveolar proteinosis by leading to an improvement in lung function and disease status.

Condition or disease Intervention/treatment Phase
Pulmonary Alveolar Proteinosis Primary Disease Drug: rituximab Phase 2

Detailed Description:
The goal of this study is to conduct a prospective, open-label 6-month trial of rituximab in patients who present with symptomatic primary or idiopathic PAP. A total of 10 subjects with primary PAP will be enrolled over 12 months at East Carolina University. Patients over age 18 with a clinical diagnosis of moderate symptomatic idiopathic PAP, established by appropriate clinical history, radiographic and physiologic findings, presence of circulating anti-GM-CSF antibody, and confirmatory findings on bronchoscopy with bronchoalveolar lavage and/or open-lung biopsy will be recruited. Patients with newly diagnosed PAP or established disease may be considered for this study.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Open-Label Trial of Rituximab for Primary Pulmonary Alveolar Proteinosis
Study Start Date : January 2007
Estimated Primary Completion Date : July 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: rituximab
IV, 1000 mg, two weeks, 2 times
Other Names:
  • Rituxan
  • MabThera


Outcome Measures
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Primary Outcome Measures :
  1. Evaluate symptomatic, physiologic and radiographic effects of therapy [ Time Frame: 6-months ]

Secondary Outcome Measures :
  1. Evaluate the overall tolerability of therapy and the requirement for therapeutic whole-lung lavage [ Time Frame: 6-months ]

Eligibility Criteria
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Information from the National Library of Medicine

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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:

  • Diagnosis of primary PAP (new or chronic) with presence of anti-GM-CSF antibody
  • Moderately symptomatic disease with PaO2 <70 on room air and on less than 6 L/min oxygen
  • Able to give written informed consent and comply with the requirements of the study
  • Adequate renal and liver function
  • Negative serum pregnancy test (for women of child bearing age) and on acceptable birth control during and after study completion

Exclusion Criteria:

  • Severe PAP and requires in-patient care and more urgent therapy with bilateral whole lung lavage
  • Treatment with any investigational agent within 4 weeks of screening
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
  • History of HIV, recurrent significant infection or recurrent bacterial infections
  • Known active bacterial, viral, fungal, mycobacterial, or other infection
  • Ongoing use of high dose steroids (>10mg/day) or unstable steroid dose
  • Significant cardiac or pulmonary disease or blood disorder
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): NCT00552461


Contacts
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Contact: Irene Marshall, PA-C 252-744-5888 marshalli@ecu.edu

Locations
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United States, North Carolina
East Carolina University Recruiting
Greenville, North Carolina, United States, 27834
Contact: Mani S Kavuru, MD    252-744-4653    kavurum@ecu.edu   
Contact: Irene Marshall, PA-C    252-744-5888    marshalli@ecu.edu   
Principal Investigator: Mani S Kavuru, MD         
Sponsors and Collaborators
East Carolina University
Genentech, Inc.
Investigators
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Principal Investigator: Mani S Kavuru, MD East Carolina University
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mani S. Kavuru, MD, Prinicipal Investigator, Professor and Division Chief Pulmonary & CCM, East Carolina University
ClinicalTrials.gov Identifier: NCT00552461    
Other Study ID Numbers: U2990s
First Posted: November 2, 2007    Key Record Dates
Last Update Posted: May 9, 2008
Last Verified: May 2008
Keywords provided by East Carolina University:
Pulmonary alveolar proteinosis
Primary Pulmonary alveolar proteinosis
Rituximab
 Idiopathic
Symptomatic
GM-CSF Antibody
Additional relevant MeSH terms:
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Pulmonary Alveolar Proteinosis
Lung Diseases
Respiratory Tract Diseases
Rituximab
Antineoplastic Agents, Immunological
 Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents