Trials / Completed
CompletedNCT01966289
SGI-110 in Combination With an Allogeneic Colon Cancer Cell Vaccine (GVAX) and Cyclophosphamide (CY) in Metastatic Colorectal Cancer (mCRC)
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CY | CY is administered intravenously at 200 mg/m2 |
| BIOLOGICAL | GVAX | GVAX is administered intradermally at 5E8 colon cancer cells + 5E7 GM-CSF secreting cells |
| DRUG | SGI-110 | SGI-110 is administered subcutaneously at 60 mg/m2 |
Timeline
- Start date
- 2014-04-14
- Primary completion
- 2020-06-06
- Completion
- 2020-06-06
- First posted
- 2013-10-21
- Last updated
- 2021-03-30
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01966289. Inclusion in this directory is not an endorsement.