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

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ClinicalTrials.gov Identifier: NCT01966289
Recruitment Status : Active, not recruiting
First Posted : October 21, 2013
Last Update Posted : January 9, 2019
Sponsor:
Collaborators:
Astex Therapeutics, Ltd
Susan Cohan Colon Cancer Foundation
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:
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 or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: CY Biological: GVAX Drug: SGI-110 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
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
Actual Study Start Date : December 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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 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




Primary Outcome Measures :
  1. 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 ]
  2. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 4 years ]

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


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
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. 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

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


Locations
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United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Astex Therapeutics, Ltd
Susan Cohan Colon Cancer Foundation
Investigators
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Principal Investigator: Nilofer Azad, MD The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT01966289     History of Changes
Other Study ID Numbers: J13138
NA_00087578 ( Other Identifier: JHMIRB )
First Posted: October 21, 2013    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Cyclophosphamide
Guadecitabine
Azacitidine
Vaccines
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