Study of Colon GVAX and Cyclophosphamide in Patients With Metastatic Colorectal Cancer

Completed · Phase 1

Conditions studied: Colorectal Cancer, Metastatic Cancer

In brief

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 cell line in sequence with an immunomodulatory dose of Cyclophosphamide

Key facts

Study ID: NCT00656123
Run by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
People needed: 9
Starts: 2008-03-01
Expected to finish: 2013-01-01
Last updated by the study team: 2019-08-14

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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