Trial record 1 of 5 for:
MEL11
Study of a Multi-Antigen Therapeutic Vaccine in Patients With Metastatic Melanoma
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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: NCT00613509 |
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Recruitment Status :
Terminated
(No safety concerns, the study was terminated due to slow enrollment. All enrolled patients were followed per protocol.)
First Posted : February 13, 2008
Results First Posted : December 17, 2010
Last Update Posted : April 14, 2016
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Sponsor:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Conditions |
Melanoma Cancer |
| Interventions |
Biological: ALVAC(2) Melanoma multi-antigen therapeutic vaccine Biological: Intron A, Interferon alpha -2b |
| Enrollment | 23 |
Participant Flow
| Recruitment Details | Participants were enrolled from 20 May 2008 to 31 March 2009 at 8 medical centers in the US and 3 medical centers in Canada. |
| Pre-assignment Details | A total of 23 participants who met the inclusion and exclusion criteria were enrolled and treated. |
| Arm/Group Title | Study Group 1: ALVAC Melanoma Vaccine | Study Group 2: Interferon Alpha-2b |
|---|---|---|
 Arm/Group Description |
Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment) | Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment) |
| Period Title: Cycle 1 | ||
| Started | 11 | 12 |
| Completed | 6 [1] | 4 [2] |
| Not Completed | 5 | 8 |
| Reason Not Completed | ||
| Adverse Event | 2 | 1 |
| Disease Progression | 2 | 6 |
| Unacceptable Toxicity | 1 | 0 |
| Other administrative reason | 0 | 1 |
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[1]
Completion of Cycle 1. 9 participants were deemed evaluable
[2]
Completion of Cycle 1. 12 participants were deemed evaluable
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| Period Title: Cycle 2 (Group 2 = Crossover) | ||
| Started | 11 | 4 |
| Completed | 11 | 4 |
| Not Completed | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Study Group 1: ALVAC Melanoma Vaccine | Study Group 2: Interferon Alpha-2b | Total | |
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Arm/Group Description |
Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment) | Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment) | Total of all reporting groups | |
| Overall Number of Baseline Participants | 11 | 12 | 23 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 11 participants | 12 participants | 23 participants | |
| <=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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| Between 18 and 65 years |
9 81.8%
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10 83.3%
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19 82.6%
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| >=65 years |
2 18.2%
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2 16.7%
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4 17.4%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 11 participants | 12 participants | 23 participants | |
| 52.6 (14.23) | 52.9 (14.34) | 52.8 (14.3) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 11 participants | 12 participants | 23 participants | |
| Female |
6 54.5%
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5 41.7%
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11 47.8%
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| Male |
5 45.5%
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7 58.3%
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12 52.2%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 11 participants | 12 participants | 23 participants |
| United States | 9 | 10 | 19 | |
| Canada | 2 | 2 | 4 | |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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.
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
Results Point of Contact
| Name/Title: | Medical Director |
| Organization: | Sanofi Pasteur Inc. |
| EMail: | RegistryContactUs@sanofipasteur.com |
| Responsible Party: | Sanofi ( Sanofi Pasteur, a Sanofi Company ) |
| ClinicalTrials.gov Identifier: | NCT00613509 |
| Other Study ID Numbers: |
MEL11 |
| First Submitted: | January 16, 2008 |
| First Posted: | February 13, 2008 |
| Results First Submitted: | September 14, 2010 |
| Results First Posted: | December 17, 2010 |
| Last Update Posted: | April 14, 2016 |