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



Status:Active, not recruiting
Conditions:Colorectal Cancer, Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 100
Updated:1/11/2019
Start Date:December 2013
End Date:December 2020

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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

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.


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
We found this trial at
1
site
Baltimore, Maryland 21231
410-955-6190
Phone: 410-614-5241
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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mi
from
Baltimore, MD
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