Study of Colon GVAX and Cyclophosphamide in Patients With Metastatic Colorectal Cancer
NCT ID: NCT00656123
Last Updated: 2019-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
9 participants
INTERVENTIONAL
2008-03-31
2013-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
SGI-110 in Combination With an Allogeneic Colon Cancer Cell Vaccine (GVAX) and Cyclophosphamide (CY) in Metastatic Colorectal Cancer (mCRC)
NCT01966289
Study of GVAX (With CY) and Pembrolizumab in MMR-p Advanced Colorectal Cancer
NCT02981524
Pilot Study of GVAX in Colorectal Cancer Cells
NCT01952730
Vaccine Therapy and Chemotherapy With or Without Tetanus Toxoid Compared With Chemotherapy Alone in Treating Patients With Metastatic Colorectal Cancer
NCT00027833
A Study of a Patient-Specific Neoantigen Vaccine in Combination With Immune Checkpoint Blockade for Patients With Metastatic Colorectal Cancer
NCT05141721
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CY and colon GVAX
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
cyclophosphamide
200 mg/m\^2 administered IV on Day 1 of Cycles 1-4
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
cyclophosphamide
200 mg/m\^2 administered IV on Day 1 of Cycles 1-4
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
120 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lei Zheng, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NA_00009345
Identifier Type: -
Identifier Source: secondary_id
J0745
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.