SGI-110 in Combination With an Allogeneic Colon Cancer Cell Vaccine (GVAX) and Cyclophosphamide (CY) in Metastatic Colorectal Cancer (mCRC)

March 26, 2021 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

A Pilot Study of SGI-110 in Combination With an Allogeneic Colon Cancer Cell Vaccine (GVAX) and Cyclophosphamide (CY) in Metastatic Colorectal Cancer (mCRC) as Maintenance Therapy

This study will be looking at whether CY/GVAX in combination with SGI-110 is effective (recruits CD45RO+ T cells to the tumor which may be a marker of anti-tumor activity) and safe in patients with metastatic colon or rectum cancers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Documented cancer of the colon or rectum who have received and are stable on first or second-line therapy regimens for metastatic colorectal cancer
  2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
  3. Adequate organ function as defined by study-specified laboratory tests
  4. Must use acceptable form of birth control through the study and for 28 days after final dose of study drug
  5. Signed informed consent form
  6. Willing and able to comply with study procedures

Exclusion Criteria:

  1. Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions
  2. Systemically active steroid use
  3. Another investigational product within 28 days prior to receiving study drug
  4. Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug
  5. Chemotherapy, radiation, hormonal, or biological cancer therapy within 28 days prior to receiving study drug
  6. Pregnant or lactating
  7. Unwilling or unable to comply with study procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1:CY/GVAX concurrently with SGI-110
During each of the four cycles, Cyclophosphamide (CY) is administered on Day 1 at 200 mg/m2, the colon cancer tumor vaccine (GVAX) is administered on Day 2 at 5E8 colon cancer cells + 5E7 Granulocyte macrophage-colony stimulating factor (GM-CSF) secreting cells, and SGI-110 is administered on Days 1-5 at 60 mg/m2. Each cycle is 28 days. Enrollment will begin first in Cohort 1 and 2. If a response to the treatment is seen in Cohorts 1 and 2, enrollment in Cohort 3 and 4 will begin.
Drug: CY
CY is administered intravenously at 200 mg/m2
Other Names:
  • Cyclophosphamide, Cytoxan
Biological: GVAX
GVAX is administered intradermally at 5E8 colon cancer cells + 5E7 GM-CSF secreting cells
Other Names:
  • Colon cancer tumor vaccine
Drug: SGI-110
SGI-110 is administered subcutaneously at 60 mg/m2
Experimental: Cohort 2: CY/GVAX after SGI-110
During each of the four cycles, SGI-110 is administered on Days 1-5 at 60 mg/m2, Cyclophosphamide (CY) is administered on Day 8 at 200 mg/m2, and the colon cancer tumor vaccine (GVAX) is administered on Day 9 at 5E8 colon cancer cells + 5E7 GM-CSF secreting cells. Each cycle is 28 days. Enrollment will begin first in Cohort 1 and 2. If a response to the treatment is seen in Cohorts 1 and 2, enrollment in Cohort 3 and 4 will begin.
Drug: CY
CY is administered intravenously at 200 mg/m2
Other Names:
  • Cyclophosphamide, Cytoxan
Biological: GVAX
GVAX is administered intradermally at 5E8 colon cancer cells + 5E7 GM-CSF secreting cells
Other Names:
  • Colon cancer tumor vaccine
Drug: SGI-110
SGI-110 is administered subcutaneously at 60 mg/m2
Experimental: Cohort 3: CY/GVAX
During each of the four cycles, Cyclophosphamide (CY) is administered on Day 1 at 200 mg/m2 and the colon cancer tumor vaccine (GVAX) is administered on Day 2 at 5E8 colon cancer cells + 5E7 GM-CSF secreting cells. Each cycle is 28 days. Enrollment will begin first in Cohort 1 and 2. If a response to the treatment is seen in Cohorts 1 and 2, enrollment in Cohort 3 and 4 will begin.
Drug: CY
CY is administered intravenously at 200 mg/m2
Other Names:
  • Cyclophosphamide, Cytoxan
Biological: GVAX
GVAX is administered intradermally at 5E8 colon cancer cells + 5E7 GM-CSF secreting cells
Other Names:
  • Colon cancer tumor vaccine
Experimental: Cohort 4: SGI-110
During each of the four cycles, SGI-110 is administered on Days 1-5 at 60 mg/m2. Each cycle is 28 days. Enrollment will begin first in Cohort 1 and 2. If a response to the treatment is seen in Cohorts 1 and 2, enrollment in Cohort 3 and 4 will begin.
Drug: SGI-110
SGI-110 is administered subcutaneously at 60 mg/m2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 4 years
4 years
Difference in CD45RO+ tumor infiltrating lymphocytes (TILs) measured by immunohistochemistry in pre and post-treatment tumor biopsies from patients with metastatic colorectal cancer
Time Frame: 4 years
4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: 4 years
4 years
Progression Free Survival (PFS)
Time Frame: 4 years
4 years
Time To Progression (TTP)
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

Astex Therapeutics, Ltd
Susan Cohan Colon Cancer Foundation

Investigators

  • Principal Investigator: Nilofer Azad, MD, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2014

Primary Completion (Actual)

June 6, 2020

Study Completion (Actual)

June 6, 2020

Study Registration Dates

First Submitted

October 10, 2013

First Submitted That Met QC Criteria

October 16, 2013

First Posted (Estimate)

October 21, 2013

Study Record Updates

Last Update Posted (Actual)

March 30, 2021

Last Update Submitted That Met QC Criteria

March 26, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • J13138
  • NA_00087578 (Other Identifier: JHMIRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metastatic Colorectal Cancer

Clinical Trials on CY

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe