We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 44 of 336 for:    "Malignant mesothelioma"

Pilot Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Malignant Mesothelioma (UAB 0901) (UAB0901)

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: NCT01204203
Recruitment Status : Completed
First Posted : September 17, 2010
Results First Posted : May 24, 2017
Last Update Posted : May 24, 2017
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Francisco Robert,MD, University of Alabama at Birmingham

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Mesothelioma
Intervention: Drug: Zometa

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Inclusion criteria included: adult patients (age>18) with unresectable Malignant Pleural Mesothelioma (MPM) who had progressed after one or more prior systemic therapies, had not received prior systemic therapy due to poor performance status (PS), and/or were unwilling to receive systemic chemotherapy.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The primary objective of this study was to evaluate the anti-tumor activity of zoledronic acid (Zometa) in subjects with unresectable, advanced Malignant Pleural Mesothelioma (MPM).

Reporting Groups
  Description
Zoledronic Acid (Zometa)

Zoledronic acid (Zometa) will be administered by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles. This will continue until progression of disease and/or intolerable toxicity.

Zoledronic acid (Zometa) will be administered IV on the first day of a 21 day cycle at a concentration of 4 mg. The treatment will take about 30-60 minutes with the infusion lasting about 15 minutes.


Participant Flow:   Overall Study
    Zoledronic Acid (Zometa)
STARTED   8 
COMPLETED   8 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Zoledronic Acid (Zometa) Zometa (zoledronic acid) 4mg will be administered by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles. This will continue until progression of disease and/or intolerable toxicity.

Baseline Measures
   Zoledronic Acid (Zometa) 
Overall Participants Analyzed 
[Units: Participants]
 8 
Age 
[Units: Years]
Median (Full Range)
 62 
 (49 to 77) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      8 100.0% 
Region of Enrollment 
[Units: Participants]
 
United States   8 


  Outcome Measures

1.  Primary:   Tumor Response Rate Following Zoledronic Acid (Zometa)   [ Time Frame: Baseline up to 28 months or until progressive disease or death ]

2.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: Baseline up to 28 months ]

3.  Secondary:   Overall Survival (OS)   [ Time Frame: Baseline up to 28 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Francisco Robert, MD
Organization: University of Alabama at Birmingham
phone: 205-934-5077
e-mail: pacorobertuab@cs.com



Responsible Party: Francisco Robert,MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01204203     History of Changes
Other Study ID Numbers: F090917002 (UAB 0901)
UAB 0901 ( Other Grant/Funding Number: Novartis CZOL446EUS144T )
First Submitted: September 15, 2010
First Posted: September 17, 2010
Results First Submitted: March 3, 2017
Results First Posted: May 24, 2017
Last Update Posted: May 24, 2017