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Cancer Vaccine Targeting Brachyury Protein in Tumors

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ClinicalTrials.gov Identifier: NCT01519817
Recruitment Status : Completed
First Posted : January 27, 2012
Results First Posted : July 31, 2017
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
James Gulley, M.D., National Cancer Institute (NCI)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Neoplasms
Malignant Solid Tumors
Colon Neoplasms
Adenocarcinoma
Intervention: Biological: GI-6301 (Yeast Brachyury Vaccine)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
4 YU (Dose Level 1) Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
16 YU (Dose Level 2) Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
40 YU (Dose Level 3) Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
80 YU (Dose Level 4) Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.

Participant Flow:   Overall Study
    4 YU (Dose Level 1)   16 YU (Dose Level 2)   40 YU (Dose Level 3)   80 YU (Dose Level 4)
STARTED   4   3   16   11 
COMPLETED   3   3   16   10 
NOT COMPLETED   1   0   0   1 
Withdrawal by Subject                1                0                0                0 
Off study due to infection                0                0                0                1 



  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.
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Reporting Groups
  Description
All Participants

All participants who received at least one dose of 4YU, 16YU, 40YU or 80YU.

Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.

GI-6301 (Yeast Brachyury Vaccine): GI-6301 is a heat-killed, recombinant yeast-based vaccine engineered to express the transcription factor, Brachyury. The Brachyury gene is used to transfect the parental yeast strain (S. cerevisiae W303 - a haploid strain with known mutations from wildtype yeast) to produce the final recombinant vaccine product.


Baseline Measures
   All Participants 
Overall Participants Analyzed 
[Units: Participants]
 34 
Age 
[Units: Participants]
Count of Participants
 
Participants Analyzed   34 
<=18 years      0   0.0% 
Between 18 and 65 years      24  70.6% 
>=65 years      10  29.4% 
Age 
[Units: Years]
Median (Full Range)
 
Participants Analyzed   34 
   58 
 (32 to 79) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed   34 
Female      15  44.1% 
Male      19  55.9% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Participants Analyzed   34 
American Indian or Alaska Native      0   0.0% 
Asian      3   8.8% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      1   2.9% 
White      30  88.2% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
 
Hispanic or Latino   
Participants Analyzed   34 
Hispanic or Latino   0 
Not Hispanic or Latino   
Participants Analyzed   34 
Not Hispanic or Latino   33 
Mexican, Puerto Rican, Cuban Central or So. Americ   
Participants Analyzed   34 
Mexican, Puerto Rican, Cuban Central or So. Americ   1 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   
Participants Analyzed   34 
United States   34 
Eastern Cooperative Oncology Group (ECOG) Performance Status [1] 
[Units: Participants]
Count of Participants
 
Participants Analyzed   34 
    14  41.2% 
    20  58.8% 
[1] ECOG: 0 is normal activity. Fully active, able to carry on all pre-disease performance without restriction. 1 is symptoms, but ambulatory. Restricted in physically strenuous activity, but ambulatory and bale to carry out work of a light or sedentary nature (e.g., light housework, office work).
Tumor Type 
[Units: Participants]
Count of Participants
 
Participants Analyzed   34 
Colorectal      11  32.4% 
Chordoma      11  32.4% 
Breast      5  14.7% 
Pancreatic      3   8.8% 
Prostate      2   5.9% 
Urothelial      1   2.9% 
Lung      1   2.9% 
Disease at Study Entry [1] [2] 
[Units: Participants]
Count of Participants
 
Carcinomas   
Participants Analyzed   23 
Stable disease      1   4.3% 
Progressive disease      22  95.7% 
Chordomas   
Participants Analyzed   11 
Stable disease      2  18.2% 
Progressive disease      9  81.8% 
[1] Stable disease does not meet criteria for complete response (disappearance of all lesions; no new lesions), partial response (≥30% decrease in the sum of greatest diameters; no new lesions), or progressive disease. Progressive disease is ≥20% increase in the sum of greatest diameters; new lesions.
[2] 23 participants with carcinomas (solid tumors) and 11 participants with chordomas.
Prior Cytotoxic Regimens [1] [2] 
[Units: Participants]
Count of Participants
 
 
Participants Analyzed   23 
 1 
1 regimen   
Participants Analyzed   23 
1 regimen   2 
2 regimens   
Participants Analyzed   23 
2 regimens   8 
≥3 regimens   
Participants Analyzed   23 
≥3 regimens   12 
[1] Cytotoxic (i.e. poisonous to cancer cells)
[2] The module refers to 23 participants with carcinomas (solid tumors).
Tumor Anatomical Location [1] [2] 
[Units: Participants]
Count of Participants
 
Sacral   
Participants Analyzed   11 
Sacral   6 
Clival   
Participants Analyzed   11 
Clival   3 
Spinal   
Participants Analyzed   11 
Spinal   2 
[1] Sacral (i.e., sacrum), spinal (i.e., backbone), and clival (i.e. base of skull).
[2] The module refers to 11 participants with chordomas.
Prior Therapy [1] [2] 
[Units: Participants]
Count of Participants
 
Surgery   
Participants Analyzed   11 
Surgery   11 
Radiotherapy   
Participants Analyzed   11 
Radiotherapy   11 
Systemic therapy   
Participants Analyzed   11 
Systemic therapy   5 
[1] Surgery, radiotherapy and systemic therapy use surgical procedures, targeted therapy with radiation, steroids, and/or other immunosuppressive agents in an attempt to suppress one or more growing lesions.
[2] The module refers to 11 participants with chordomas.


  Outcome Measures

1.  Primary:   Number of Participants With Brachyury-Specific T-cell Responses   [ Time Frame: Baseline (pre-vaccination) and approximately day 84 (after 6 vaccinations) ]

2.  Primary:   Count of Participants With Adverse Events of Escalating Doses of Yeast Brachyury ( GI- 6301) Vaccine   [ Time Frame: 4 years and 25 days ]

3.  Secondary:   Number of Participants With a Clinical Benefit Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)   [ Time Frame: 3 and 5 months restaging ]

4.  Secondary:   Changes in Immune Cell Subsets in Peripheral Blood Mononuclear Cells (PBMC)   [ Time Frame: Pre (Baseline) and Day 85 after 6 vaccinations ]

5.  Secondary:   Changes in Serum Levels of Cytokines   [ Time Frame: Pre (Baseline) and Day 85 after 6 vaccinations ]

6.  Secondary:   Changes in Soluble Cluster of Differentiation 27 (sCD27)   [ Time Frame: Pre (Baseline) and Day 85 after 6 vaccinations ]

7.  Secondary:   Median Ratio of Soluble Cluster of Differentiation 27:40L (sCD27:sCD40L)   [ Time Frame: Pre (Baseline) and Day 85 after 6 vaccinations ]

8.  Secondary:   Changes in Soluble Cluster of Differentiation 40L (sCD40L)   [ Time Frame: Pre (Baseline) and Day 85 after 6 vaccinations ]


  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
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  More Information

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


Results Point of Contact:  
Name/Title: Dr. James Gulley
Organization: National Cancer Institute
phone: 301-480-8870
e-mail: gulleyj@mail.nih.gov


Publications of Results:
Other Publications:

Responsible Party: James Gulley, M.D., National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01519817     History of Changes
Other Study ID Numbers: 120056
12-C-0056
First Submitted: January 12, 2012
First Posted: January 27, 2012
Results First Submitted: February 27, 2017
Results First Posted: July 31, 2017
Last Update Posted: January 29, 2018