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

This study is currently recruiting participants.
Verified July 2017 by Sidney Kimmel Comprehensive Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01966289
First Posted: October 21, 2013
Last Update Posted: July 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
  Purpose
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.

Condition Intervention Phase
Metastatic Colorectal Cancer Drug: CY Biological: GVAX Drug: SGI-110 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 ]
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 4 years ]

Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: 4 years ]
  • Time To Progression (TTP) [ Time Frame: 4 years ]
  • Progression Free Survival (PFS) [ Time Frame: 4 years ]

Estimated Enrollment: 32
Actual Study Start Date: December 2013
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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 Name: Cyclophosphamide, Cytoxan
Biological: GVAX
GVAX is administered intradermally at 5E8 colon cancer cells + 5E7 GM-CSF secreting cells
Other Name: 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 Name: Cyclophosphamide, Cytoxan
Biological: GVAX
GVAX is administered intradermally at 5E8 colon cancer cells + 5E7 GM-CSF secreting cells
Other Name: 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 Name: Cyclophosphamide, Cytoxan
Biological: GVAX
GVAX is administered intradermally at 5E8 colon cancer cells + 5E7 GM-CSF secreting cells
Other Name: 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01966289


Contacts
Contact: Carol Judkins, RN 410-614-5241 judkica@jhmi.edu
Contact: Nilofer Azad, MD nazad2@jhmi.edu

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21231
Contact: Carol Judkins, RN    410-614-5241    judkica@jhmi.edu   
Contact: Nilofer Azad, MD       nazad2@jhmi.edu   
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Nilofer Azad, MD The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  More Information

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01966289     History of Changes
Other Study ID Numbers: J13138
NA_00087578 ( Other Identifier: JHMIRB )
First Submitted: October 10, 2013
First Posted: October 21, 2013
Last Update Posted: July 11, 2017
Last Verified: July 2017

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
Colonic Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

Additional relevant MeSH terms:
Colonic Diseases
Colorectal Neoplasms
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Vaccines
Cyclophosphamide
Azacitidine
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites
Enzyme Inhibitors