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Safety Study of Adjuvant Vaccine to Treat Melanoma Patients

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ClinicalTrials.gov Identifier: NCT01079741
Recruitment Status : Completed
First Posted : March 3, 2010
Results First Posted : February 13, 2018
Last Update Posted : February 13, 2018
Sponsor:
Collaborators:
Ludwig Institute for Cancer Research
Oncovir, Inc.
Cancer Research Institute, New York City
Information provided by (Responsible Party):
Nina Bhardwaj, Icahn School of Medicine at Mount Sinai

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Melanoma
Intervention: Biological: NY-ESO-1 protein; Poly-ICLC; Montanide

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Poly-ICLC 0.35mg Cohort 1 100µg NY-ESO-1 protein + 1.1 mL Montanide + 0.35mg Poly-ICLC. The cycle was repeated every 3 weeks for a total of 4 cycles.
Poly-ICLC 0.7mg Cohort 2 100 µg NY-ESO-1 protein + 1.1 mL Montanide + 0.7mg Poly-ICLC.The cycle was repeated every 3 weeks for a total of 4 cycles.
Poly-ICLC 1.4mg Cohort 3 100 µg NY-ESO-1 protein + 1.1 mL Montanide + 1.4 mg Poly-ICLC. The cycle was repeated every 3 weeks for a total of 4 cycles.
NY-ESO-1 Protein and Poly-ICLC Phase 2, Arm 1 100μg NY-ESO-1 protein, 1.4mg Poly-ICLC.
NY-ESO-1 Protein, Poly-ICLC and Montanide Phase 2, Arm 2 100μg NY-ESO-1 protein, 1.4mg Poly-ICLC and 1.1mL Montanide.

Participant Flow for 4 periods

Period 1:   Cohort 1: Dose Level 1 (Weeks 1-12)
    Poly-ICLC 0.35mg   Poly-ICLC 0.7mg   Poly-ICLC 1.4mg   NY-ESO-1 Protein and Poly-ICLC   NY-ESO-1 Protein, Poly-ICLC and Montanide
STARTED   3   0   0   0   0 
COMPLETED   3   0   0   0   0 
NOT COMPLETED   0   0   0   0   0 

Period 2:   Cohort 2: Dose Level 2 (Weeks 13-24)
    Poly-ICLC 0.35mg   Poly-ICLC 0.7mg   Poly-ICLC 1.4mg   NY-ESO-1 Protein and Poly-ICLC   NY-ESO-1 Protein, Poly-ICLC and Montanide
STARTED   0   4   0   0   0 
COMPLETED   0   3   0   0   0 
NOT COMPLETED   0   1   0   0   0 
Disease Progression                0                1                0                0                0 

Period 3:   Cohort 3: Dose Level 3 (Weeks 25-36)
    Poly-ICLC 0.35mg   Poly-ICLC 0.7mg   Poly-ICLC 1.4mg   NY-ESO-1 Protein and Poly-ICLC   NY-ESO-1 Protein, Poly-ICLC and Montanide
STARTED   0   0   3   0   0 
COMPLETED   0   0   0   0   0 
NOT COMPLETED   0   0   3   0   0 

Period 4:   Phase 2 (Weeks 37-48)
    Poly-ICLC 0.35mg   Poly-ICLC 0.7mg   Poly-ICLC 1.4mg   NY-ESO-1 Protein and Poly-ICLC   NY-ESO-1 Protein, Poly-ICLC and Montanide
STARTED   0   0   0   12   12 
COMPLETED   0   0   0   12   9 
NOT COMPLETED   0   0   0   0   3 
Withdrawal by Subject                0                0                0                0                3 



  Baseline Characteristics

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
Poly-ICLC 0.35 mg Cohort 1 100µg NY-ESO-1 protein + 1.1 mL Montanide + 0.35mg Poly-ICLC. The cycle was repeated every 3 weeks for a total of 4 cycles.
Poly-ICLC 0.70 mg 100 µg NY-ESO-1 protein + 1.1 mL Montanide + 0.7mg Poly-ICLC.The cycle was repeated every 3 weeks for a total of 4 cycles.
Poly-ICLC 1.4mg 100 µg NY-ESO-1 protein + 1.1 mL Montanide + 1.4 mg Poly-ICLC. The cycle was repeated every 3 weeks for a total of 4 cycles.
NY-ESO-1 Protein and Poly-ICLC 100μg NY-ESO-1 protein, 1.4mg Poly-ICLC.
NY-ESO-1 Protein, Poly-ICLC and Montanide 100μg NY-ESO-1 protein, 1.4mg Poly-ICLC and 1.1mL Montanide.
Total Total of all reporting groups

Baseline Measures
   Poly-ICLC 0.35 mg   Poly-ICLC 0.70 mg   Poly-ICLC 1.4mg   NY-ESO-1 Protein and Poly-ICLC   NY-ESO-1 Protein, Poly-ICLC and Montanide   Total 
Overall Participants Analyzed 
[Units: Participants]
 3   4   3   12   12   34 
Age 
[Units: Years]
Median (Full Range)
 64 
 (42 to 72) 
 65 
 (39 to 74) 
 73 
 (64 to 78) 
 50 
 (21 to 69) 
 57 
 (24 to 83) 
 55 
 (21 to 74) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female      0   0.0%      2  50.0%      0   0.0%      5  41.7%      6  50.0%      13  38.2% 
Male      3 100.0%      2  50.0%      3 100.0%      7  58.3%      6  50.0%      21  61.8% 
Pathologic Staging [1] 
[Units: Participants]
Count of Participants
           
IIA   0   0   0   1   0   1 
IIB   0   0   1   1   0   2 
IIC   1   0   0   0   1   2 
IIIA   1   0   0   0   2   3 
IIIB   1   1   0   4   3   9 
IIIC   0   3   2   4   4   13 
IV   0   0   0   2   2   4 
[1] IIA - Melanoma thickness1-2mm with ulceration or 2-4mm without ulceration; IIB - 2-4 mm thickness with ulceration or 4mm without ulceration IIC - thickness >4mm with ulceration IIIA - thickness any size, no ulcerations, 1-3 nodes micrometasis IIIB - thickness any size, 1-3 nodes, with or without ulcerations, micrometasis or macrometasis IIIC - thickness any size, with or without ulcerations 1-3 nodes, micrometasis, marcrometasis, or in transit mets(s)/satellite(s) without metastatic nodes IV - any thickness, with or without ulcerations, nay nodes, any distant metastases


  Outcome Measures

1.  Primary:   Phase I, Number of Participants With SAE and DLT   [ Time Frame: 52 weeks ]

2.  Secondary:   CD4+ and CD8+ Response   [ Time Frame: Up to 52 weeks ]

3.  Secondary:   NY-ESO-1 Expression by IHC   [ Time Frame: up to 52 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Nina Bhardwaj
Organization: Icahn School of Medicine at Mount Sinai
phone: 212-824-8427
e-mail: nina.bhardwaj@mssm.edu



Responsible Party: Nina Bhardwaj, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01079741     History of Changes
Other Study ID Numbers: GCO 13-1391
First Submitted: March 2, 2010
First Posted: March 3, 2010
Results First Submitted: April 8, 2017
Results First Posted: February 13, 2018
Last Update Posted: February 13, 2018