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

Phase 1

Completed

• Conditions: Colorectal Cancer; Metastatic Cancer
• Interventions: Biological: Colon GVAX; Drug: cyclophosphamide

• Registration Number: NCT00656123
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-04-09
• Study First Submitted QC: 2008-04-09
• Study First Posted: 2008-04-10
• Primary Completion: 2011-08
• Study Completion: 2013-01
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-12
• Last Update Posted: 2019-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CY and colon GVAX	Colon GVAX	-
CY and colon GVAX	cyclophosphamide	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States