Phase 1 Trial of Guadecitabine With Vaccine and Cyclophosphamide for Metastatic Colorectal Cancer

Share this content:
Researchers are evaluating whether guadecitabine (SGI-110), a DNA methyltransferase inhibitor, is safe and effective in combination with cyclophosphamide and GVAX among patients with colorectal cancer
Researchers are evaluating whether guadecitabine (SGI-110), a DNA methyltransferase inhibitor, is safe and effective in combination with cyclophosphamide and GVAX among patients with colorectal cancer

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 Therapy1

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

Description: For this randomized, open-label, phase 1 trial, researchers are evaluating whether guadecitabine (SGI-110), a DNA methyltransferase inhibitor, is safe and effective in combination with cyclophosphamide and GVAX, a colon cancer tumor vaccine, among patients with metastatic colorectal cancer.

All patients will initially receive cyclophosphamide, GVAX, and guadecitabine; if a response is recorded, patients will be assigned to receive cyclophosphamide and GVAX or guadecitabine alone.

The primary outcome measures are the difference in CD45RO+ tumor infiltrating lymphocytes in biopsies taken before/after treatment and the number of adverse events. Secondary outcomes include overall and progression-free survival.

For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT01966289.

Status: This study is open and recruiting patients as of October 23, 2017.

This study is sponsored by the Sidney Kimmel Comprehensive Cancer Center.

Reference

  1. Clinicaltrials.gov. SGI-110 in combination with an allogeneic colon cancer cell vaccine (GVAX) and cyclophosphamide (CY) in metastatic colorectal cancer (mCRC).  NCT01966289. https://clinicaltrials.gov/ct2/show/NCT01966289. Accessed October 23, 2017.

Related Resources

You must be a registered member of Cancer Therapy Advisor to post a comment.

Regimen and Drug Listings

GET FULL LISTINGS OF TREATMENT Regimens and Drug INFORMATION

Bone Cancer Regimens Drugs
Brain Cancer Regimens Drugs
Breast Cancer Regimens Drugs
Endocrine Cancer Regimens Drugs
Gastrointestinal Cancer Regimens Drugs
Gynecologic Cancer Regimens Drugs
Head and Neck Cancer Regimens Drugs
Hematologic Cancer Regimens Drugs
Lung Cancer Regimens Drugs
Other Cancers Regimens
Prostate Cancer Regimens Drugs
Rare Cancers Regimens
Renal Cell Carcinoma Regimens Drugs
Skin Cancer Regimens Drugs
Urologic Cancers Regimens Drugs

Sign Up for Free e-newsletters