SGI-110 in Combination With an Allogeneic Colon Cancer Cell Vaccine (GVAX) and Cyclophosphamide (CY) in Metastatic Colorectal Cancer (mCRC)
A Pilot Study of SGI-110 in Combination With an Allogeneic Colon Cancer Cell Vaccine (GVAX) and Cyclophosphamide (CY) in Metastatic Colorectal Cancer (mCRC) as Maintenance Therapy
2 other identifiers
interventional
18
1 country
1
Brief Summary
This study will be looking at whether CY/GVAX in combination with SGI-110 is effective (recruits CD45RO+ T cells to the tumor which may be a marker of anti-tumor activity) and safe in patients with metastatic colon or rectum cancers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Apr 2014
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2013
CompletedFirst Posted
Study publicly available on registry
October 21, 2013
CompletedStudy Start
First participant enrolled
April 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 6, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 6, 2020
CompletedMarch 30, 2021
March 1, 2021
6.2 years
October 10, 2013
March 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Difference in CD45RO+ tumor infiltrating lymphocytes (TILs) measured by immunohistochemistry in pre and post-treatment tumor biopsies from patients with metastatic colorectal cancer
4 years
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
4 years
Secondary Outcomes (3)
Overall Survival (OS)
4 years
Time To Progression (TTP)
4 years
Progression Free Survival (PFS)
4 years
Study Arms (4)
Cohort 1:CY/GVAX concurrently with SGI-110
EXPERIMENTALDuring each of the four cycles, Cyclophosphamide (CY) is administered on Day 1 at 200 mg/m2, the colon cancer tumor vaccine (GVAX) is administered on Day 2 at 5E8 colon cancer cells + 5E7 Granulocyte macrophage-colony stimulating factor (GM-CSF) secreting cells, and SGI-110 is administered on Days 1-5 at 60 mg/m2. Each cycle is 28 days. Enrollment will begin first in Cohort 1 and 2. If a response to the treatment is seen in Cohorts 1 and 2, enrollment in Cohort 3 and 4 will begin.
Cohort 2: CY/GVAX after SGI-110
EXPERIMENTALDuring each of the four cycles, SGI-110 is administered on Days 1-5 at 60 mg/m2, Cyclophosphamide (CY) is administered on Day 8 at 200 mg/m2, and the colon cancer tumor vaccine (GVAX) is administered on Day 9 at 5E8 colon cancer cells + 5E7 GM-CSF secreting cells. Each cycle is 28 days. Enrollment will begin first in Cohort 1 and 2. If a response to the treatment is seen in Cohorts 1 and 2, enrollment in Cohort 3 and 4 will begin.
Cohort 3: CY/GVAX
EXPERIMENTALDuring each of the four cycles, Cyclophosphamide (CY) is administered on Day 1 at 200 mg/m2 and the colon cancer tumor vaccine (GVAX) is administered on Day 2 at 5E8 colon cancer cells + 5E7 GM-CSF secreting cells. Each cycle is 28 days. Enrollment will begin first in Cohort 1 and 2. If a response to the treatment is seen in Cohorts 1 and 2, enrollment in Cohort 3 and 4 will begin.
Cohort 4: SGI-110
EXPERIMENTALDuring each of the four cycles, SGI-110 is administered on Days 1-5 at 60 mg/m2. Each cycle is 28 days. Enrollment will begin first in Cohort 1 and 2. If a response to the treatment is seen in Cohorts 1 and 2, enrollment in Cohort 3 and 4 will begin.
Interventions
CY is administered intravenously at 200 mg/m2
GVAX is administered intradermally at 5E8 colon cancer cells + 5E7 GM-CSF secreting cells
SGI-110 is administered subcutaneously at 60 mg/m2
Eligibility Criteria
You may qualify if:
- Documented cancer of the colon or rectum who have received and are stable on first or second-line therapy regimens for metastatic colorectal cancer
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
- Adequate organ function as defined by study-specified laboratory tests
- Must use acceptable form of birth control through the study and for 28 days after final dose of study drug
- Signed informed consent form
- Willing and able to comply with study procedures
You may not qualify if:
- Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions
- Systemically active steroid use
- Another investigational product within 28 days prior to receiving study drug
- Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug
- Chemotherapy, radiation, hormonal, or biological cancer therapy within 28 days prior to receiving study drug
- Pregnant or lactating
- Unwilling or unable to comply with study procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231, United States
Related Publications (1)
Bever KM, Thomas DL 2nd, Zhang J, Diaz Rivera EA, Rosner GL, Zhu Q, Nauroth JM, Christmas B, Thompson ED, Anders RA, Judkins C, Liu M, Jaffee EM, Ahuja N, Zheng L, Azad NS. A feasibility study of combined epigenetic and vaccine therapy in advanced colorectal cancer with pharmacodynamic endpoint. Clin Epigenetics. 2021 Feb 2;13(1):25. doi: 10.1186/s13148-021-01014-8.
PMID: 33531075DERIVED
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nilofer Azad, MD
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2013
First Posted
October 21, 2013
Study Start
April 14, 2014
Primary Completion
June 6, 2020
Study Completion
June 6, 2020
Last Updated
March 30, 2021
Record last verified: 2021-03