NCT00656123

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1 colorectal-cancer

Timeline
Completed

Started Mar 2008

Typical duration for phase_1 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 9, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 10, 2008

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

3.4 years

First QC Date

April 9, 2008

Last Update Submit

August 12, 2019

Conditions

Colorectal CancerMetastatic Cancer

Keywords

adenocarcinoma of the colonadenocarcinoma of the rectumstage IV colon cancerstage IV rectal cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Percent Fold change in amount of interferon gamma-producing Ep-CAM-specific CD8 T cells after vaccination

    5 years

Study Arms (1)

CY and colon GVAX

EXPERIMENTAL
Biological: Colon GVAXDrug: cyclophosphamide

Interventions

Colon GVAXBIOLOGICAL

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

Also known as: Allogeneic Colon Cancer Cell Vaccine Administered with a Granulocyte-Macrophage Colony Stimulating Factor-Producing Bystander Cell Line
CY and colon GVAX
cyclophosphamideDRUG

200 mg/m\^2 administered IV on Day 1 of Cycles 1-4

CY and colon GVAX

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

Related 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 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.

    PMID: 24943235RESULT

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasm MetastasisColonic NeoplasmsRectal Neoplasms

Interventions

Cyclophosphamide

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Lei Zheng, MD, PhD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2008

First Posted

April 10, 2008

Study Start

March 1, 2008

Primary Completion

August 1, 2011

Study Completion

January 1, 2013

Last Updated

August 14, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)