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

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins9 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colorectal Cancer Metastatic Cancer

Interventions

Colon GVAXBIOLOGICAL

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

cyclophosphamideDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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.

Time frame: 3.5 years

Secondary Outcomes

Percent Fold change in amount of interferon gamma-producing Ep-CAM-specific CD8 T cells after vaccination

Time frame: 5 years

Data from ClinicalTrials.gov

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