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Evaluate The Toxicity And Feasibility Of Intra-Tumoral Injection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Giles Whalen, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT00668382
First received: April 25, 2008
Last updated: May 10, 2013
Last verified: May 2013
History of Changes
Results First Received: October 25, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: Neoplasm Metastases
Intervention: Biological: Alpha-Gal Glycosphingolipid

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients recruited from medical and surgical oncology clinics with currently untreatable tumors from march 2007 through June 2011

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No assignment to separate arms, Patients had to be off any active treatment for their advanced tumors for at least 2 weeks before entry onto study and a month after. Two subjects withdrew after screening and consent because of stroke (1) and insurance refusal(1). Two patients dropped out in the first month due to treatment needs.

Reporting Groups
  Description
Alpha-Gal Glycosphingolipid Injection Intervention: Intratumoral injection of a single dose of Alpha-Gal Glycosphingolipid (0.1 mg,1mg, 10mg)

Participant Flow:   Overall Study
    Alpha-Gal Glycosphingolipid Injection  
STARTED     11 [1]
COMPLETED     11  
NOT COMPLETED     0  
[1] beginning of trial



  Baseline Characteristics
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Reporting Groups
  Description
Alpha-Gal Glycosphingolipid Injection Intervention: Intratumoral injection of a single dose of Alpha-Gal Glycosphingolipid (0.1 mg,1mg, 10mg)

Baseline Measures
    Alpha-Gal Glycosphingolipid Injection  
Number of Participants  
[units: participants]
 		  11  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     7  
>=65 years     4  
Age  
[units: years]
Mean ± Standard Deviation 		  60  ± 12.5  
Gender  
[units: participants]
 		 
Female     3  
Male     8  
Region of Enrollment  
[units: participants]
 		 
United States     11  



  Outcome Measures

1.  Primary:   Number of Subjects With Greater Than Grade 3 or 4 Toxicity   [ Time Frame: 1 month ]
  Show Outcome Measure 1


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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 allergic/immune toxicity. The single toxicity/AE was bacterial infection with UGI flora at injection site following EUS (endoscopic ultra-sound) guided injection of pancreatic cancer. Added injections covered with antibiotic prophylaxis.  


Results Point of Contact:  
Name/Title: Dr. Sheila Noone
Organization: UMass Medical Scool
phone: 508 856 5015
e-mail: Sheil.Noone@umasmed.edu


Publications of Results:


Responsible Party: Giles Whalen, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT00668382     History of Changes
Other Study ID Numbers: UM200702
Study First Received: April 25, 2008
Results First Received: October 25, 2012
Last Updated: May 10, 2013
Health Authority: United States: Food and Drug Administration