A Clinical Study, to Evaluate the Safety and Tolerability of Intradermal IMM-101 in Adult Melanoma Cancer Patients

This study has been completed.
Sponsor:
Collaborators:
HCA International Limited
Theradex
Information provided by (Responsible Party):
Immodulon Therapeutics Ltd
ClinicalTrials.gov Identifier:
NCT01308762
First received: February 16, 2011
Last updated: November 8, 2012
Last verified: September 2012
Results First Received: March 30, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Subject)
Condition: Melanoma
Interventions: Biological: Heat killed whole cell M. obuense (IMM-101) 0.1 mg
Biological: Heat-killed whole cell M.obuense (IMM-101) 0.5 mg
Biological: Heat killed whole cell M.obuense (IMM-101) 1.0 mg

  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
A total of 24 patients with melanoma entered the screening phase of this study between 10 March 2010 and 27 July 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Five patients were found to be ineligible and failed screening. These patients were withdrawn before receiving study medication.

Reporting Groups
  Description
IMM-101 0.1 mg Patients received an intradermal injection of IMM-101 0.1 mg on three occasions. Doses were administered over a four week period on days 0, 14 and 28.
IMM-101 0.5 mg Patients received an intradermal injection of IMM-101 0.5 mg on three occasions. Doses were administered over a four week period on days 0, 14 and 28.
IMM-101 1.0 mg Patients received an intradermal injection of IMM-101 1.0 mg on three occasions. Doses were administered over a four week period on days 0, 14 and 28.

Participant Flow:   Overall Study
    IMM-101 0.1 mg     IMM-101 0.5 mg     IMM-101 1.0 mg  
STARTED     6     7     6  
COMPLETED     6     6 [1]   6  
NOT COMPLETED     0     1     0  
Protocol Violation                 0                 1                 0  
[1] One patient was withdrawn as they were retrospecively found to have been ineligible at study entry



  Baseline Characteristics
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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
Group 1 IMM-101 0.1 mg
Group 2 IMM-101 0.5 mg
Group 3 IMM-101 1.0 mg
Total Total of all reporting groups

Baseline Measures
    Group 1     Group 2     Group 3     Total  
Number of Participants  
[units: participants]
  6     7     6     19  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     5     3     3     11  
>=65 years     1     4     3     8  
Age  
[units: years]
Mean ± Standard Deviation
  47.3  ± 17.3     56.1  ± 20.2     56.3  ± 18.8     53.4  ± 18.3  
Gender  
[units: participants]
       
Female     2     3     3     8  
Male     4     4     3     11  
Region of Enrollment  
[units: participants]
       
United Kingdom     6     7     6     19  



  Outcome Measures
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1.  Primary:   Number of Participants With Adverse Events as a Measure of Safety and Tolerability   [ Time Frame: 56 days ]

2.  Secondary:   Administration Site Reactions   [ Time Frame: Day -3 to Day 56 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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.  


Results Point of Contact:  
Name/Title: Clinical Trials Co-ordinator
Organization: Immodulon Therapeutics, The London Clinic Cancer Centre, London W1G 6JA,
phone: +44 (0)203 219 3568/3572
e-mail: Ilda@immodulon.com


No publications provided by Immodulon Therapeutics Ltd

Publications automatically indexed to this study:

Responsible Party: Immodulon Therapeutics Ltd
ClinicalTrials.gov Identifier: NCT01308762     History of Changes
Other Study ID Numbers: IMM-101-001, 2009-012447-42
Study First Received: February 16, 2011
Results First Received: March 30, 2011
Last Updated: November 8, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency