A Study of 1018 Immunostimulatory Sequence (ISS) Administered With Irinotecan and Cetuximab to Treat Patients With Previously Treated Metastatic Colorectal Cancer

Stopped early · Phase 1

Conditions studied: Colorectal Neoplasms

In brief

The main objectives of this study are to establish a safe, tolerable and active dose of 1018 ISS administered in combination with irinotecan and cetuximab in patients with metastatic colorectal cancer. Other objectives also include determining tumor response, time to disease progression, and overall survival in treated patients.

Key facts

Study ID

NCT00403052

Run by

Dynavax Technologies Corporation

People needed

14

Starts

2006-11-01

Expected to finish

2007-12-01

Last updated by the study team

2019-04-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed, written, informed consent must be obtained from the patient or their legal representative before any study-specific procedures are performed
• Confirmed diagnosis of adenocarcinoma of the colon or rectum not amenable to curative surgery
• One or more prior systemic therapy regimens for metastatic cancer which must have included a fluoropyrimidine (5-fluorouracil (FU) by infusion or capecitabine), oxaliplatin or irinotecan with or without bevacizumab

You may not qualify if…

• Clinically significant obstructive symptoms, intestinal bleeding, or chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom
• History of unstable or deteriorating cardiovascular or cerebrovascular disease within 3 months before the first dose of protocol therapy
• Clinical evidence of brain metastases or central nervous system disease
• Pregnant or lactating women
• Serious medical or psychiatric illness
• Malignancy other than colorectal carcinoma within the past 2 years, except curatively treated, superficial skin cancer or carcinoma in situ of the cervix
• Patients who have been on any experimental study or anti-tumor therapy, received radiotherapy, or had prior surgery (except venous access device placement) within 28 days before the first dose of protocol therapy

Where it is running

• Premiere Oncology — Santa Monica, California, United States
• Lombardi Comprehensive Cancer Center, Georgetown University — Washington D.C., District of Columbia, United States
• Center for Cancer and Blood Disorders — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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