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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
Dynavax Technologies Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

First Posted
November 21, 2006
Last Updated
April 11, 2019
Sponsor
Dynavax Technologies Corporation
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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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