Trial Outcomes & Findings for Trial of Melaxin Cancer Vaccine Plus Bacillus Calmette-Guerin (BCG) to Treat Malignant Melanoma (NCT NCT00671554)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

3 participants

Primary outcome timeframe

From first vaccine to 18 months after the last injection

Results posted on

2014-06-04

Participant Flow

Participant milestones

Participant milestones
Measure	Melaxin 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.
Overall Study STARTED	3
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Melaxin 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.
Overall Study Disease progression	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Melaxin n=3 Participants Melaxin vaccine in conjunction with Bacillus Calmette-Guerin (BCG)
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants
Age, Categorical >=65 years	2 Participants n=93 Participants
Age, Continuous	70 years STANDARD_DEVIATION 5.29 • n=93 Participants
Sex: Female, Male Female	1 Participants n=93 Participants
Sex: Female, Male Male	2 Participants n=93 Participants
Region of Enrollment United States	3 participants n=93 Participants

PRIMARY outcome

Timeframe: From first vaccine to 18 months after the last injection

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.

Outcome measures

Outcome measures
Measure	Melaxin n=3 Participants Melaxin vaccine in conjunction with Bacillus Calmette-Guerin (BCG)
Safety as Measured by Number of Participants With Unexpected Adverse Events or Unexpected Laboratory Results.	0 participants

SECONDARY outcome

Timeframe: From first vaccine to 18 months after the last injection

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.

Outcome measures

Outcome measures
Measure	Melaxin n=3 Participants Melaxin vaccine in conjunction with Bacillus Calmette-Guerin (BCG)
Tumor Response Measured by RECIST Criteria and Progression-free Survival.	0 participants

Adverse Events

Melaxin

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Melaxin n=3 participants at risk Melaxin vaccine in conjunction with Bacillus Calmette-Guerin (BCG)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain Metastasis	66.7% 2/3 • Number of events 2 • first dose to 6 weeks after last dose
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Death due to disease progression	33.3% 1/3 • Number of events 1 • first dose to 6 weeks after last dose
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Post-Operative meningitis	33.3% 1/3 • Number of events 1 • first dose to 6 weeks after last dose
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Post-operative wound infection	33.3% 1/3 • Number of events 1 • first dose to 6 weeks after last dose
Skin and subcutaneous tissue disorders injection site reactions	66.7% 2/3 • Number of events 2 • first dose to 6 weeks after last dose

Other adverse events

Other adverse events
Measure	Melaxin n=3 participants at risk Melaxin vaccine in conjunction with Bacillus Calmette-Guerin (BCG)
Gastrointestinal disorders nausea	66.7% 2/3 • Number of events 2 • first dose to 6 weeks after last dose
General disorders fatigue	66.7% 2/3 • Number of events 2 • first dose to 6 weeks after last dose
Skin and subcutaneous tissue disorders Injection site reactions	66.7% 2/3 • Number of events 2 • first dose to 6 weeks after last dose

Additional Information

Joe Stephenson, MD

Greenville Hospital System

Phone: 864-455-3600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place