Metastatic Colorectal Cancer
Conditions
Keywords
Colorectal Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Neoplasms, Digestive System Diseases, Gastrointestinal Diseases, Colonic Diseases, Intestinal Diseases, Rectal Diseases
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.
Interventions
Sponsors
Astex Therapeutics, Ltd
Susan Cohan Colon Cancer Foundation
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | 4 years |
| Time To Progression (TTP) | 4 years |
| Progression Free Survival (PFS) | 4 years |
Countries
United States
Outcome results
None listed