Clinical trial NCT00656123: Study of Colon GVAX and Cyclophosphamide in Patients With Metastatic Colorectal Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Colorectal Cancer
Metastatic Cancer
Keywords: adenocarcinoma of the colon
adenocarcinoma of the rectum
stage IV colon cancer
stage IV rectal cancer
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-04-10
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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


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

Primary outcomes:
measure: Number of Patients Experiencing a Grade 3 or Above Treatment-related Toxicity
timeFrame: 3.5 years
Secondary outcomes:
measure: Percent Fold change in amount of interferon gamma-producing Ep-CAM-specific CD8 T cells after vaccination
timeFrame: 5 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Lei Zheng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 stimulating factor-producing bystander cell line in patients with metastatic colorectal cancer. Ann Surg Oncol. 2014 Nov;21(12):3931-7. doi: 10.1245/s10434-014-3844-x. Epub 2014 Jun 19.