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

Colorectal Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00403052
• Other study ID #: DV2-ONC-01
• Status: Terminated
• Phase: Phase 1
• Start date: November 2006
• Est. completion date: December 2007

Study information

• Verified date: April 2019
• Source: Dynavax Technologies Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Drug:
• 1018 ISS immunostimulatory oligonucleotide
6 weekly subcutaneous (under the skin) injections

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Dynavax Technologies Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of adverse events		16 weeks
Secondary	Time to tumor progression		9 or more weeks
Secondary	Overall survival time		9 or more weeks

External Links

•   Dynavax Webpage