Colon Cancer Clinical Trial

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

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

View Eligibility Criteria

Eligibility 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

Study is for people with:

Colon Cancer

Phase:

Phase 1

Estimated Enrollment:

9

Study ID:

NCT00656123

Recruitment Status:

Completed

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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There is 1 Location for this study

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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore Maryland, 21231, United States

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 1

Estimated Enrollment:

9

Study ID:

NCT00656123

Recruitment Status:

Completed

Sponsor:


Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

How clear is this clinincal trial information?

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