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| ID | Type | Description | Link |
|---|---|---|---|
| NA_00087578 | Other Identifier | JHMIRB |
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| Name | Class |
|---|---|
| Astex Therapeutics, Ltd | UNKNOWN |
| Susan Cohan Colon Cancer Foundation | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1:CY/GVAX concurrently with SGI-110 | Experimental | During each of the four cycles, Cyclophosphamide (CY) is administered on Day 1 at 200 mg/m2, the colon cancer tumor vaccine (GVAX) is administered on Day 2 at 5E8 colon cancer cells + 5E7 Granulocyte macrophage-colony stimulating factor (GM-CSF) secreting cells, and SGI-110 is administered on Days 1-5 at 60 mg/m2. Each cycle is 28 days. Enrollment will begin first in Cohort 1 and 2. If a response to the treatment is seen in Cohorts 1 and 2, enrollment in Cohort 3 and 4 will begin. |
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| Cohort 2: CY/GVAX after SGI-110 | Experimental | During each of the four cycles, SGI-110 is administered on Days 1-5 at 60 mg/m2, Cyclophosphamide (CY) is administered on Day 8 at 200 mg/m2, and the colon cancer tumor vaccine (GVAX) is administered on Day 9 at 5E8 colon cancer cells + 5E7 GM-CSF secreting cells. Each cycle is 28 days. Enrollment will begin first in Cohort 1 and 2. If a response to the treatment is seen in Cohorts 1 and 2, enrollment in Cohort 3 and 4 will begin. |
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| Cohort 3: CY/GVAX | Experimental | During each of the four cycles, Cyclophosphamide (CY) is administered on Day 1 at 200 mg/m2 and the colon cancer tumor vaccine (GVAX) is administered on Day 2 at 5E8 colon cancer cells + 5E7 GM-CSF secreting cells. Each cycle is 28 days. Enrollment will begin first in Cohort 1 and 2. If a response to the treatment is seen in Cohorts 1 and 2, enrollment in Cohort 3 and 4 will begin. |
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| Cohort 4: SGI-110 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CY | Drug | CY is administered intravenously at 200 mg/m2 |
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| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | 4 years | |
| Time To Progression (TTP) | 4 years | |
| Progression Free Survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nilofer Azad, MD | The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33531075 | Derived | Bever KM, Thomas DL 2nd, Zhang J, Diaz Rivera EA, Rosner GL, Zhu Q, Nauroth JM, Christmas B, Thompson ED, Anders RA, Judkins C, Liu M, Jaffee EM, Ahuja N, Zheng L, Azad NS. A feasibility study of combined epigenetic and vaccine therapy in advanced colorectal cancer with pharmacodynamic endpoint. Clin Epigenetics. 2021 Feb 2;13(1):25. doi: 10.1186/s13148-021-01014-8. |
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| Experimental |
During each of the four cycles, SGI-110 is administered on Days 1-5 at 60 mg/m2. Each cycle is 28 days. Enrollment will begin first in Cohort 1 and 2. If a response to the treatment is seen in Cohorts 1 and 2, enrollment in Cohort 3 and 4 will begin. |
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| GVAX | Biological | GVAX is administered intradermally at 5E8 colon cancer cells + 5E7 GM-CSF secreting cells |
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| SGI-110 | Drug | SGI-110 is administered subcutaneously at 60 mg/m2 |
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| 4 years |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| C580831 | guadecitabine |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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