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

Primary Purpose

Colorectal Cancer, Metastatic Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Colon GVAX
cyclophosphamide
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring adenocarcinoma of the colon, adenocarcinoma of the rectum, stage IV colon cancer, stage IV rectal cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CY and colon GVAX

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 9, 2008
Last Updated
August 12, 2019
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00656123
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 2008 (Actual)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Metastatic Cancer
Keywords
adenocarcinoma of the colon, adenocarcinoma of the rectum, stage IV colon cancer, stage IV rectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CY and colon GVAX
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Colon GVAX
Other Intervention Name(s)
Allogeneic Colon Cancer Cell Vaccine Administered with a Granulocyte-Macrophage Colony Stimulating Factor-Producing Bystander Cell Line
Intervention Description
Dose escalation: 1.4x10^8 to 7x10^8 cells administered in up to 15 intradermal injections on Day 2 of Cycles 1-4
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Description
200 mg/m^2 administered IV on Day 1 of Cycles 1-4
Primary Outcome Measure Information:
Title
Number of Patients Experiencing a Grade 3 or Above Treatment-related Toxicity
Description
When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v3) will be counted only once for a given subject.
Time Frame
3.5 years
Secondary Outcome Measure Information:
Title
Percent Fold change in amount of interferon gamma-producing Ep-CAM-specific CD8 T cells after vaccination
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lei Zheng, MD, PhD
Organizational Affiliation
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24943235
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.
Results Reference
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Study of Colon GVAX and Cyclophosphamide in Patients With Metastatic Colorectal Cancer

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