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Randomized Phase II Adjuvant Chemotherapy ± FANG™ in Colorectal Carcinoma With Liver Metastases (FANG-CLM)

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ClinicalTrials.gov Identifier: NCT01505166
Recruitment Status : Terminated (Terminated (Business Decision to pursue other indications))
First Posted : January 6, 2012
Results First Posted : May 1, 2018
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Gradalis, Inc.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Colon Cancer
Interventions: Biological: Vigil™ Vaccine
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study recruited patients with colorectal carcinoma with liver metastases following resection and had successful manufacturing of Vigil (minimum of 4 doses). Part 1 would enroll the first 6 patients (Vigil plus chemotherapy) and then Part 2 would randomize subsequent patients (Vigil plus chemotherapy or Placebo plus chemotherapy).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
3 subjects were enrolled in Part 1 and completed Vigil plus chemotherapy. No other subjects were enrolled in Part 1 and also Part 2.

Reporting Groups
  Description
Vigil™ Vaccine (Part 1) - 6 Patient run-in

Six patients will be enrolled into the Part 1 of the study to receive intradermal autologous Vigil™ cancer vaccine (1.0 x 10e7 cells/injection; maximum of 12 vaccinations).

Vigil™ Vaccine: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks).

Vigil™ (Part 2)

Patients will receive 1 x 10^7 cells (Group A) via intradermal injection for a minimum of 4 doses and a maximum of 12 doses (vaccine) starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days.

Vigil™ Vaccine: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks).

Placebo (Part 2)

Patients will receive placebo (Group B) via intradermal injection for a minimum of 4 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days.

Placebo: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks).


Participant Flow:   Overall Study
    Vigil™ Vaccine (Part 1) - 6 Patient run-in   Vigil™ (Part 2)   Placebo (Part 2)
STARTED   3   0   0 
COMPLETED   3 [1]   0   0 
NOT COMPLETED   0   0   0 
[1] "Completed" means subject had successful Vigil manufacturing and had been given all the doses.



  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
Vigil™ Vaccine (Part 1) 6 Patient run-in

Six patients will be enrolled into the Part 1 of the study to receive intradermal autologous Vigil™ cancer vaccine (1.0 x 10e7 cells/injection; maximum of 12 vaccinations).

Vigil™ Vaccine: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks).

Vigil™ (Part 2)

Patients will receive 1 x 10^7 cells (Group A) via intradermal injection for a minimum of 4 doses and a maximum of 12 doses (vaccine) starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days.

Vigil™ Vaccine: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks).

Placebo (Part 2)

Patients will receive placebo (Group B) via intradermal injection for a minimum of 4 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days.

Placebo: Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks).

Total Total of all reporting groups

Baseline Measures
   Vigil™ Vaccine (Part 1) 6 Patient run-in   Vigil™ (Part 2)   Placebo (Part 2)   Total 
Overall Participants Analyzed 
[Units: Participants]
 3   0   0   3 
Age, Customized 
[Units: Participants]
Count of Participants
       
0-15 Years   0         0 
16-64 Years   2         2 
65 Years and Older   1         1 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      2  66.7%            2  66.7% 
Male      1  33.3%            1  33.3% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
       
White/Caucasian      3 100.0%            3 100.0% 
Black/African American      0   0.0%            0   0.0% 
Asian      0   0.0%            0   0.0% 
Hispanic      0   0.0%            0   0.0% 
Other      0   0.0%            0   0.0% 


  Outcome Measures

1.  Primary:   Immune Analysis in Tumor Biopsy and Blood (Part 1)   [ Time Frame: Up to 12 months ]

2.  Primary:   Percent of Patients Who Progressed After Treatment (Part 2)   [ Time Frame: 24 months ]

3.  Primary:   Percent of Patients Who Survived After Treatment (Part 2)   [ Time Frame: 24 months ]

4.  Other Pre-specified:   Enzyme-Linked ImmunoSorbent Spot (ELISPOT) (Part 1)   [ Time Frame: Baseline, End of Treatment (30 days after last dose) up to 12 months ]

5.  Other Pre-specified:   Number of Alive Subjects (Part 1)   [ Time Frame: 24 Months ]


  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:  
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.


Results Point of Contact:  
Name/Title: Director of Clinical Trials
Organization: Gradalis, Inc.
phone: 2144428124
e-mail: info@gradalisinc.com


Publications:

Responsible Party: Gradalis, Inc.
ClinicalTrials.gov Identifier: NCT01505166     History of Changes
Other Study ID Numbers: CL-PTL 107
First Submitted: January 4, 2012
First Posted: January 6, 2012
Results First Submitted: February 15, 2018
Results First Posted: May 1, 2018
Last Update Posted: June 25, 2018