Colorectal CancerPhase 1NCT00656123
Study of Colon GVAX and Cyclophosphamide in Patients With Metastatic Colorectal Cancer
A Phase 1 study testing Colon GVAX and cyclophosphamide in people with Colorectal Cancer and Metastatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Colorectal Cancer, Metastatic Cancer
- What is being tested?
- Colon GVAX and cyclophosphamide
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Jan 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
About this study
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
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
- Conditions
- Colorectal Cancer, Metastatic Cancer
- Being tested
- Colon GVAX, cyclophosphamide
- Keywords
- adenocarcinoma of the colon, adenocarcinoma of the rectum, stage IV colon cancer, stage IV rectal cancer
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colon GVAXBiological
Also called Allogeneic Colon Cancer Cell Vaccine Administered with a Granulocyte-Macrophage Colony Stimulating Factor-Producing Bystander Cell Line
Dose escalation: 1.4x10^8 to 7x10^8 cells administered in up to 15 intradermal injections on Day 2 of Cycles 1-4
cyclophosphamideDrug
200 mg/m^2 administered IV on Day 1 of Cycles 1-4
| Study group | Role | What they receive |
|---|---|---|
| CY and colon GVAX | Experimental | Not described Receives: Biological: Colon GVAX; Drug: cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3.5 years
Secondary outcomes (1)
Percent Fold change in amount of interferon gamma-producing Ep-CAM-specific CD8 T cells after vaccination
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionAug 2011
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lei Zheng, MD, PhD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00656123
- Sponsor's protocol ID
- J0745
- Other IDs
- NA_00009345
- Status last verified
- Aug 2019
- First submitted
- 9 Apr 2008
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24943235
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00656123
- Acronym / sponsor ID
- J0745
- Conditions
- Colorectal Cancer, Metastatic Cancer
- Keywords
- adenocarcinoma of the colon, adenocarcinoma of the rectum, stage IV colon cancer, stage IV rectal cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2008 (actual)
- Primary completion
- Aug 2011 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 10 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CY and colon GVAX | Experimental | Biological: Colon GVAX, Drug: cyclophosphamide |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colon GVAXAlso: Allogeneic Colon Cancer Cell Vaccine Administered with a Granulocyte-Macrophage Colony Stimulating Factor-Producing Bystander Cell LineDose escalation: 1.4x10^8 to 7x10^8 cells administered in up to 15 intradermal injections on Day 2 of Cycles 1-4 | Biological | CY and colon GVAX |
| cyclophosphamide200 mg/m^2 administered IV on Day 1 of Cycles 1-4 | Drug | CY and colon GVAX |
Primary outcome
Number of Patients Experiencing a Grade 3 or Above Treatment-related Toxicity
Time frame: 3.5 years
When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v3) will be counted only once for a given subject.
1 secondary outcome
Percent Fold change in amount of interferon gamma-producing Ep-CAM-specific CD8 T cells after vaccination
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Results publication: PubMed 24943235Zheng 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lei Zheng, MD, PhD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Colon GVAX and cyclophosphamide in people with Colorectal Cancer and Metastatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients Experiencing a Grade 3 or Above Treatment-related Toxicity (time frame: 3.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00656123, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019.