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

• Status: Completed
• Trial end date: 2020-06-06
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: Astex Therapeutics, Ltd; Susan Cohan Colon Cancer Foundation
• Treatments: Azacitidine; Cyclophosphamide; Guadecitabine; Vaccines

Criteria

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