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

Study Overview
=================
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 cell line in sequence with an immunomodulatory dose of Cyclophosphamide

Official Title
-----------------
A Safety and Feasibility Study of an Allogeneic Colon Cancer Cell Vaccine Administered With a GM-CSF Producing Bystander Cell Line in Patients With Metastatic Colorectal Cancer

Conditions
-----------------
Colorectal Cancer, Metastatic Cancer

Intervention / Treatment
-----------------
* Biological: Colon GVAX
* Drug: cyclophosphamide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CY and colon GVAX<br> | Biological: Colon GVAX<br>* Dose escalation: 1.4x10^8 to 7x10^8 cells administered in up to 15 intradermal injections on Day 2 of Cycles 1-4<br>* Other names: Allogeneic Colon Cancer Cell Vaccine Administered with a Granulocyte-Macrophage Colony Stimulating Factor-Producing Bystander Cell Line;Drug: cyclophosphamide<br>* 200 mg/m^2 administered IV on Day 1 of Cycles 1-4<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Experiencing a Grade 3 or Above Treatment-related Toxicity | When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v3) will be counted only once for a given subject. | 3.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Fold change in amount of interferon gamma-producing Ep-CAM-specific CD8 T cells after vaccination |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adenocarcinoma of the colon, adenocarcinoma of the rectum, stage IV colon cancer, stage IV rectal cancer