SGI-110 in Combination With an Allogeneic Colon Cancer Cell Vaccine (GVAX) and Cyclophosphamide (CY) in Metastatic Colorectal Cancer (mCRC)

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other)

Overall Status

Completed

CT.gov ID

NCT01966289

Collaborator

Astex Therapeutics, Ltd (Other), Susan Cohan Colon Cancer Foundation (Other)

Enrollment

Location

Arms

73.8

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Colorectal Cancer	Drug: CY Biological: GVAX Drug: SGI-110	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 14, 2014

Actual Primary Completion Date :

Jun 6, 2020

Actual Study Completion Date :

Jun 6, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1:CY/GVAX concurrently with SGI-110 During 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.	Drug: CY CY is administered intravenously at 200 mg/m2 Other Names: Cyclophosphamide, Cytoxan Biological: GVAX GVAX is administered intradermally at 5E8 colon cancer cells + 5E7 GM-CSF secreting cells Other Names: Colon cancer tumor vaccine Drug: SGI-110 SGI-110 is administered subcutaneously at 60 mg/m2
Experimental: Cohort 2: CY/GVAX after SGI-110 During 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.	Drug: CY CY is administered intravenously at 200 mg/m2 Other Names: Cyclophosphamide, Cytoxan Biological: GVAX GVAX is administered intradermally at 5E8 colon cancer cells + 5E7 GM-CSF secreting cells Other Names: Colon cancer tumor vaccine Drug: SGI-110 SGI-110 is administered subcutaneously at 60 mg/m2
Experimental: Cohort 3: CY/GVAX During 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.	Drug: CY CY is administered intravenously at 200 mg/m2 Other Names: Cyclophosphamide, Cytoxan Biological: GVAX GVAX is administered intradermally at 5E8 colon cancer cells + 5E7 GM-CSF secreting cells Other Names: Colon cancer tumor vaccine
Experimental: Cohort 4: SGI-110 During 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.	Drug: SGI-110 SGI-110 is administered subcutaneously at 60 mg/m2

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Overall Survival (OS) [4 years]
Time To Progression (TTP) [4 years]
Progression Free Survival (PFS) [4 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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