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

Metastatic Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01966289
• Other study ID #: J13138
• Secondary ID: NA_00087578
• Status: Completed
• Phase: Phase 1
• Start date: April 14, 2014
• Est. completion date: June 6, 2020

Study information

• Verified date: March 2021
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 6, 2020
• Est. primary completion date: June 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Documented cancer of the colon or rectum who have received and are stable on first or second-line therapy regimens for metastatic colorectal cancer

2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1

3. Adequate organ function as defined by study-specified laboratory tests

4. Must use acceptable form of birth control through the study and for 28 days after final dose of study drug

5. Signed informed consent form

6. Willing and able to comply with study procedures

Exclusion Criteria:

1. Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions

2. Systemically active steroid use

3. Another investigational product within 28 days prior to receiving study drug

4. Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug

5. Chemotherapy, radiation, hormonal, or biological cancer therapy within 28 days prior to receiving study drug

6. Pregnant or lactating

7. Unwilling or unable to comply with study procedures

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• CY
CY is administered intravenously at 200 mg/m2

Biological:
• GVAX
GVAX is administered intradermally at 5E8 colon cancer cells + 5E7 GM-CSF secreting cells

Drug:
• SGI-110
SGI-110 is administered subcutaneously at 60 mg/m2

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Astex Therapeutics, Ltd, Susan Cohan Colon Cancer Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		4 years
Secondary	Overall Survival (OS)		4 years
Secondary	Time To Progression (TTP)		4 years
Secondary	Progression Free Survival (PFS)		4 years