Status:
TERMINATED
A Study of 1018 Immunostimulatory Sequence (ISS) Administered With Irinotecan and Cetuximab to Treat Patients With Previously Treated Metastatic Colorectal Cancer
Lead Sponsor:
Dynavax Technologies Corporation
Conditions:
Colorectal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
This is a Phase I, open-label study of escalating dose levels of 1018 ISS in combination with irinotecan and cetuximab in patients with previously treated metastatic colorectal cancer. Approximately 1...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00403052
Start Date
November 1 2006
End Date
December 1 2007
Last Update
April 16 2019
Active Locations (3)
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1
Premiere Oncology
Santa Monica, California, United States, 90404
2
Lombardi Comprehensive Cancer Center, Georgetown University
Washington D.C., District of Columbia, United States, 20007
3
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817