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

• Status: Terminated
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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. Other objectives also include determining tumor response, time to disease progression, and overall survival in treated patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dynavax Technologies Corporation
• Treatments: 1018 oligonucleotide; Cetuximab; Irinotecan

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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