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Therapeutic Angiotensin-(1-7) in Treating Patients With Metastatic Sarcoma That Cannot Be Removed By Surgery

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ClinicalTrials.gov Identifier: NCT01553539
Recruitment Status : Completed
First Posted : March 14, 2012
Results First Posted : January 30, 2014
Last Update Posted : July 4, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Bone Cancer
Chondrosarcoma
Clear Cell Sarcoma of the Kidney
Metastatic Osteosarcoma
Ovarian Sarcoma
Recurrent Adult Soft Tissue Sarcoma
Recurrent Osteosarcoma
Recurrent Uterine Sarcoma
Stage III Adult Soft Tissue Sarcoma
Stage III Uterine Sarcoma
Stage IV Adult Soft Tissue Sarcoma
Stage IV Uterine Sarcoma
Interventions: Drug: therapeutic angiotensin-(1-7)
Other: laboratory biomarker analysis

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Treatment (Antiangiogenesis Therapy) Patients receive therapeutic angiotensin-(1-7) subcutaneous (SC) once daily in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Treatment (Antiangiogenesis Therapy)
STARTED   20 
COMPLETED   20 
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.
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Reporting Groups
  Description
Treatment (Antiangiogenesis Therapy) Patients receive therapeutic angiotensin-(1-7) SC once daily in the absence of disease progression or unacceptable toxicity.

Baseline Measures
   Treatment (Antiangiogenesis Therapy) 
Overall Participants Analyzed 
[Units: Participants]
 20 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      18  90.0% 
>=65 years      2  10.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.4  (14.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      9  45.0% 
Male      11  55.0% 
Region of Enrollment 
[Units: Participants]
 
United States   20 


  Outcome Measures

1.  Primary:   Antitumor Activity as Assessed by Number of Patients Showing an Objective Tumor Response   [ Time Frame: Approximately 1 year ]

2.  Primary:   Number of Participants Who Experienced Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0   [ Time Frame: Approximately 1 year ]

3.  Secondary:   Time to Disease Progression   [ Time Frame: Approximately 5 years ]

4.  Secondary:   Overall Survival   [ Time Frame: Approximately 5 years ]

5.  Secondary:   Plasma Levels of Angiogenic Peptides Including Placental Growth Factor (PlGF)   [ Time Frame: Baseline and Day 22 ]


  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
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. William J. Petty
Organization: Wake Forest University Health Sciences
phone: 336-716-3313
e-mail: wpetty@wakehealth.edu



Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01553539     History of Changes
Obsolete Identifiers: NCT00974545
Other Study ID Numbers: IRB00008212
NCI-2009-01259 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
003936-01A2 ( Other Grant/Funding Number: FDA OOPD )
CCCWFU 71108 ( Other Identifier: Wake Forest University Health Sciences )
First Submitted: March 9, 2012
First Posted: March 14, 2012
Results First Submitted: November 15, 2013
Results First Posted: January 30, 2014
Last Update Posted: July 4, 2018