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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00656123

Enrollment

Registered

2008-04-10

Start date

2008-03-31

Completion date

2013-01-31

Last updated

2019-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Metastatic Cancer

Keywords

adenocarcinoma of the colon, adenocarcinoma of the rectum, stage IV colon cancer, stage IV rectal cancer

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

Interventions

BIOLOGICALColon GVAX

Dose escalation: 1.4x10\^8 to 7x10\^8 cells administered in up to 15 intradermal injections on Day 2 of Cycles 1-4

DRUGcyclophosphamide

200 mg/m\^2 administered IV on Day 1 of Cycles 1-4

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 120 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026