Status:
COMPLETED
Study of Colon GVAX and Cyclophosphamide in Patients With Metastatic Colorectal Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer
Metastatic Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
Brief Summary
The primary objective of this study is to evaluate the safety and feasibility of vaccination with two irradiated allogeneic colorectal carcinoma cells administered with a GM-CSF producing bystander ce...
Eligibility Criteria
Inclusion
- Documented metastatic colorectal cancer
- 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
- Life expectance \> 12 weeks
Exclusion
- 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, or biological cancer therapy within 28 days prior to receiving study drug
- No known history or evidence of CNS metastases \< 2 years.
- Pregnant or lactating
- Unwilling or unable to comply with study procedures
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00656123
Start Date
March 1 2008
End Date
January 1 2013
Last Update
August 14 2019
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231