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Trial record 74 of 2090 for:    cancer vaccine

Trial of Melaxin Cancer Vaccine Plus Bacillus Calmette-Guerin (BCG) to Treat Malignant Melanoma

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ClinicalTrials.gov Identifier: NCT00671554
Recruitment Status : Terminated (Due to business considerations; not due to toxicities or adverse events.)
First Posted : May 5, 2008
Results First Posted : June 4, 2014
Last Update Posted : June 4, 2014
Sponsor:
Collaborator:
Oncolix, Inc.
Information provided by (Responsible Party):
Prisma Health-Upstate

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Melanoma
Intervention Biological: Melaxin (autologous dendritoma vaccine) and BCG
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Melaxin
Hide Arm/Group Description Melaxin vaccine in conjunction with Bacillus Calmette-Guerin (BCG). Four 1 ml doses of 250,000 dendritomas Subcutaneous (SQ) at 4 week intervals along with a separate SQ injection containing 1 million Colony Forming Units (CFU) of BCG. The dose of BCG will be decreased by 50% in subsequent dosing if there is injection site ulceration.
Period Title: Overall Study
Started 3
Completed 0
Not Completed 3
Reason Not Completed
Disease progression             3
Arm/Group Title Melaxin
Hide Arm/Group Description Melaxin vaccine in conjunction with Bacillus Calmette-Guerin (BCG)
Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
  33.3%
>=65 years
2
  66.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants
70  (5.29)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
1
  33.3%
Male
2
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
1.Primary Outcome
Title Safety as Measured by Number of Participants With Unexpected Adverse Events or Unexpected Laboratory Results.
Hide Description Expected adverse events included injection site reactions, fever, chills, and arthralgias as anticipated with vaccine therapy. No unexpected or uncommon adverse events occurred such as disseminated sepsis. Clinical laboratory results on all participants were within expected ranges, including an increase in the number of IFN gamma expressing T-cells.
Time Frame From first vaccine to 18 months after the last injection
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Melaxin
Hide Arm/Group Description:
Melaxin vaccine in conjunction with Bacillus Calmette-Guerin (BCG)
Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: participants
0
2.Secondary Outcome
Title Tumor Response Measured by RECIST Criteria and Progression-free Survival.
Hide Description CT scans for disease assessment occurred at three month intervals. If partial or complete responses were observed confirmation scans were performed within four weeks. Patients were followed for 18 months post study completion. All three participants recieved at least one vaccine, and all participants had progression of disease prior to the 18 month followup visit.
Time Frame From first vaccine to 18 months after the last injection
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Melaxin and BCG
Hide Arm/Group Description:

Four 1 ml doses of 250,000 dendritomas SQ at 4 week intervals along with a separate SQ injection containing 1 million Colony Forming Units (CFU) of BCG. The dose of BCG will be decreased by 50% in subsequent dosing if there is injection site ulceration

Melaxin (autologous dendritoma vaccine) and BCG: Four 1 ml doses of 250,000 dendritomas SQ at 4 week intervals along with a separate SQ injection containing 1 million CFU of BCG. The dose of BCG will be decreased by 50% in subsequent dosing if there is injection site ulceration.

Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: participants
0
Time Frame first dose to 6 weeks after last dose
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Melaxin
Hide Arm/Group Description Melaxin vaccine in conjunction with Bacillus Calmette-Guerin (BCG)
All-Cause Mortality
Melaxin
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Melaxin
Affected / at Risk (%) # Events
Total   2/3 (66.67%)    
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Brain Metastasis  1  2/3 (66.67%)  2
Death due to disease progression  1  1/3 (33.33%)  1
Post-Operative meningitis  1  1/3 (33.33%)  1
Post-operative wound infection  1  1/3 (33.33%)  1
Skin and subcutaneous tissue disorders   
injection site reactions  2  2/3 (66.67%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
2
Term from vocabulary, 1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Melaxin
Affected / at Risk (%) # Events
Total   3/3 (100.00%)    
Gastrointestinal disorders   
nausea  1  2/3 (66.67%)  2
General disorders   
fatigue  1  2/3 (66.67%)  2
Skin and subcutaneous tissue disorders   
Injection site reactions  2  2/3 (66.67%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
2
Term from vocabulary, 1
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
Layout table for Results Point of Contact information
Name/Title: Joe Stephenson, MD
Organization: Greenville Hospital System
Phone: 864-455-3600
EMail: joe.stephenson@usoncology.com
Layout table for additonal information
Responsible Party: Prisma Health-Upstate
ClinicalTrials.gov Identifier: NCT00671554    
Other Study ID Numbers: CC/ORI 07-02
First Submitted: April 30, 2008
First Posted: May 5, 2008
Results First Submitted: April 3, 2012
Results First Posted: June 4, 2014
Last Update Posted: June 4, 2014