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

Johns Hopkins Medicine

Status and phase

Completed

Phase 1

Conditions

Metastatic Cancer

Colorectal Cancer

Treatments

Drug: cyclophosphamide

Biological: Colon GVAX

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00656123

J0745

NA_00009345

Details and patient eligibility

About

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

Enrollment

9 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No 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