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

Sponsor

Dynavax Technologies Corporation (Industry)

Overall Status

Terminated

CT.gov ID

NCT00403052

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

4.7

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Neoplasms	Drug: 1018 ISS immunostimulatory oligonucleotide	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase 1 Study of the Combination of 1018 ISS, Irinotecan and Cetuximab in Patients With Metastatic Colorectal Cancer Previously Treated With a Fluoropyrimidine, Oxaliplatin or Irinotecan With or Without Bevacizumab

Study Start Date :

Nov 1, 2006

Actual Primary Completion Date :

Dec 1, 2007

Actual Study Completion Date :

Dec 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Low dose of 1018 ISS	Drug: 1018 ISS immunostimulatory oligonucleotide 6 weekly subcutaneous (under the skin) injections
Experimental: 2 Middle dose of 1018 ISS	Drug: 1018 ISS immunostimulatory oligonucleotide 6 weekly subcutaneous (under the skin) injections
Experimental: 3 High dose of 1018 ISS	Drug: 1018 ISS immunostimulatory oligonucleotide 6 weekly subcutaneous (under the skin) injections

Arm

Intervention/Treatment

Experimental: 1

Low dose of 1018 ISS

Drug: 1018 ISS immunostimulatory oligonucleotide

6 weekly subcutaneous (under the skin) injections

Experimental: 2

Middle dose of 1018 ISS

Drug: 1018 ISS immunostimulatory oligonucleotide

6 weekly subcutaneous (under the skin) injections

Experimental: 3

High dose of 1018 ISS

Drug: 1018 ISS immunostimulatory oligonucleotide

6 weekly subcutaneous (under the skin) injections

Outcome Measures

Primary Outcome Measures

Occurrence of adverse events [16 weeks]

Secondary Outcome Measures

Time to tumor progression [9 or more weeks]
Overall survival time [9 or more weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Premiere Oncology	Santa Monica	California	United States	90404
2	Lombardi Comprehensive Cancer Center, Georgetown University	Washington	District of Columbia	United States	20007
3	Center for Cancer and Blood Disorders	Bethesda	Maryland	United States	20817