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

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cyclophosphamide; Molgramostim; Sargramostim; Vaccines

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