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

Phase 1

Terminated

• Conditions: Colorectal Neoplasms
• Interventions: Drug: 1018 ISS immunostimulatory oligonucleotide

• Registration Number: NCT00403052
• Lead Sponsor: Dynavax Technologies Corporation

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

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 15 patients will be treated. The objectives of this study are to establish a safe, tolerable, and active dose of 1018 ISS, determine tumor response, time to disease progression, and overall survival in treated patients.

The safety and tolerability of 1018 ISS will be evaluated by periodic laboratory assessments, physical examinations, and compilation of adverse events.

Once study patients have been consented, screened, and assigned to one of the dose levels of 1018 ISS, patients will receive two 4 week cycles of 1018 ISS therapy plus irinotecan every other week and cetuximab weekly. Irinotecan and cetuximab will continue thereafter until disease progression, unacceptable toxicity, or until the patient refuses treatment.

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-11-21
• Study First Submitted QC: 2006-11-21
• Study First Posted: 2006-11-23
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-11
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	1018 ISS immunostimulatory oligonucleotide	Low dose of 1018 ISS
2	1018 ISS immunostimulatory oligonucleotide	Middle dose of 1018 ISS
3	1018 ISS immunostimulatory oligonucleotide	High dose of 1018 ISS

Primary Outcome Measures

Name	Time	Method
Occurrence of adverse events	16 weeks

Secondary Outcome Measures

Name	Time	Method
Time to tumor progression	9 or more weeks
Overall survival time	9 or more weeks

Trial Locations

Locations (3)

Center for Cancer and Blood Disorders; 🇺🇸 Bethesda, Maryland, United States

Premiere Oncology; 🇺🇸 Santa Monica, California, United States

Lombardi Comprehensive Cancer Center, Georgetown University; 🇺🇸 Washington, District of Columbia, United States