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

NCT01966289 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2021-03-30

No results posted yet for this study

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.

Conditions

Interventions

DRUG

CY

CY is administered intravenously at 200 mg/m2

BIOLOGICAL

GVAX

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

DRUG

SGI-110

SGI-110 is administered subcutaneously at 60 mg/m2

Sponsors & Collaborators

  • Astex Therapeutics, Ltd

    collaborator UNKNOWN

  • Susan Cohan Colon Cancer Foundation

    collaborator UNKNOWN

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Nilofer Azad, MD · The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-14
Primary Completion
2020-06-06
Completion
2020-06-06

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01966289 on ClinicalTrials.gov