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

Colorectal Cancer Clinical Trial

Official title:

A Safety and Feasibility Study of an Allogeneic Colon Cancer Cell Vaccine Administered With a GM-CSF Producing Bystander Cell Line in Patients With Metastatic Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00656123
• Other study ID #: J0745
• Secondary ID: NA_00009345
• Status: Completed
• Phase: Phase 1
• Start date: March 2008
• Est. completion date: January 2013

Study information

• Verified date: August 2019
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: January 2013
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

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

Drug:
• cyclophosphamide
200 mg/m^2 administered IV on Day 1 of Cycles 1-4

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Zheng L, Edil BH, Soares KC, El-Shami K, Uram JN, Judkins C, Zhang Z, Onners B, Laheru D, Pardoll D, Jaffee EM, Schulick RD. A safety and feasibility study of an allogeneic colon cancer cell vaccine administered with a granulocyte-macrophage colony stimul — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3.5 years
Secondary	Percent Fold change in amount of interferon gamma-producing Ep-CAM-specific CD8 T cells after vaccination		5 years