A Study of 1018 Immunostimulatory Sequence (ISS) Administered With Irinotecan and Cetuximab to Treat Patients With Previously Treated Metastatic Colorectal Cancer
Primary Purpose
Colorectal Neoplasms
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
1018 ISS immunostimulatory oligonucleotide
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Neoplasms focused on measuring colorectal, cancer, carcinoma, metastatic, colon, rectal, neoplasm, cetuximab, irinotecan, 1018 ISS, combination therapy
Eligibility 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
Sites / Locations
- Premiere Oncology
- Lombardi Comprehensive Cancer Center, Georgetown University
- Center for Cancer and Blood Disorders
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
1
2
3
Arm Description
Low dose of 1018 ISS
Middle dose of 1018 ISS
High dose of 1018 ISS
Outcomes
Primary Outcome Measures
Occurrence of adverse events
Secondary Outcome Measures
Time to tumor progression
Overall survival time
Full Information
NCT ID
NCT00403052
First Posted
November 21, 2006
Last Updated
April 11, 2019
Sponsor
Dynavax Technologies Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00403052
Brief Title
A Study of 1018 Immunostimulatory Sequence (ISS) Administered With Irinotecan and Cetuximab to Treat Patients With Previously Treated Metastatic Colorectal Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
Administrative reasons
Study Start Date
November 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dynavax Technologies Corporation
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
colorectal, cancer, carcinoma, metastatic, colon, rectal, neoplasm, cetuximab, irinotecan, 1018 ISS, combination therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Low dose of 1018 ISS
Arm Title
2
Arm Type
Experimental
Arm Description
Middle dose of 1018 ISS
Arm Title
3
Arm Type
Experimental
Arm Description
High dose of 1018 ISS
Intervention Type
Drug
Intervention Name(s)
1018 ISS immunostimulatory oligonucleotide
Intervention Description
6 weekly subcutaneous (under the skin) injections
Primary Outcome Measure Information:
Title
Occurrence of adverse events
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Time to tumor progression
Time Frame
9 or more weeks
Title
Overall survival time
Time Frame
9 or more weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo Martins, MD, DPhil
Organizational Affiliation
Dynavax Technologies Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Premiere Oncology
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Lombardi Comprehensive Cancer Center, Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Center for Cancer and Blood Disorders
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
3/2017 No change in status of this study
Links:
URL
http://www.dynavax.com
Description
Dynavax Webpage
Learn more about this trial
A Study of 1018 Immunostimulatory Sequence (ISS) Administered With Irinotecan and Cetuximab to Treat Patients With Previously Treated Metastatic Colorectal Cancer
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