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Completed

NCT Number: NCT01966289

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

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.

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Key information

Conditions

Metastatic Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Documented cancer of the colon or rectum who have received and are stable on first or second-line therapy regimens for metastatic colorectal cancer
  • Eastern Cooperative Oncology Group (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
  • Willing and able to comply with study procedures

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, hormonal, or biological cancer therapy within 28 days prior to receiving study drug
  • Pregnant or lactating
  • Unwilling or unable to comply with study procedures

Treatment and study plan

CY

Drug

CY is administered intravenously at 200 mg/m2

Other names: Cyclophosphamide, Cytoxan

GVAX

Biological

GVAX is administered intradermally at 5E8 colon cancer cells + 5E7 GM-CSF secreting cells

Other names: Colon cancer tumor vaccine

SGI-110

Drug

SGI-110 is administered subcutaneously at 60 mg/m2

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Collaborators

  • Astex Therapeutics, Ltd
  • Susan Cohan Colon Cancer Foundation

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Oct 21, 2013
Registry last updated
Mar 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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