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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00403052
Recruitment Status : Terminated (Administrative reasons)
First Posted : November 23, 2006
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Dynavax Technologies Corporation

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : November 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007
Arms and Interventions
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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
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Primary Outcome Measures :
  1. Occurrence of adverse events [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Time to tumor progression [ Time Frame: 9 or more weeks ]
  2. Overall survival time [ Time Frame: 9 or more weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00403052


Locations
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United States, California
Premiere Oncology
Santa Monica, California, United States, 90404
United States, District of Columbia
Lombardi Comprehensive Cancer Center, Georgetown University
Washington, District of Columbia, United States, 20007
United States, Maryland
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817
Sponsors and Collaborators
Dynavax Technologies Corporation
Investigators
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Study Director: Eduardo Martins, MD, DPhil Dynavax Technologies Corporation
More Information
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Additional Information:

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Responsible Party: Dynavax Technologies Corporation
ClinicalTrials.gov Identifier: NCT00403052    
Other Study ID Numbers: DV2-ONC-01
First Posted: November 23, 2006    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: 3/2017 No change in status of this study
Keywords provided by Dynavax Technologies Corporation:
colorectal
cancer
carcinoma
metastatic
colon
rectal
 neoplasm
cetuximab
irinotecan
1018 ISS
combination therapy
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
 Colonic Diseases
Intestinal Diseases
Rectal Diseases
1018 oligonucleotide
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs