Colon Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Colon Cancer

Phase:

Phase 1

Estimated Enrollment:

18

Study ID:

NCT01966289

Recruitment Status:

Completed

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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There is 1 Location for this study

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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore Maryland, 21231, United States

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 1

Estimated Enrollment:

18

Study ID:

NCT01966289

Recruitment Status:

Completed

Sponsor:


Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

How clear is this clinincal trial information?

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