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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

Tracking Information
First Submitted Date  ICMJE November 21, 2006
First Posted Date  ICMJE November 23, 2006
Last Update Posted Date April 16, 2019
Study Start Date  ICMJE November 2006
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2007)
Occurrence of adverse events [ Time Frame: 16 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 21, 2006)
To establish the safety and tolerability of escalating dose levels of 1018 ISS administered with irinotecan and cetuximab in patients with previously treated metastatic colorectal cancer.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2007)
  • Time to tumor progression [ Time Frame: 9 or more weeks ]
  • Overall survival time [ Time Frame: 9 or more weeks ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of 1018 Immunostimulatory Sequence (ISS) Administered With Irinotecan and Cetuximab to Treat Patients With Previously Treated Metastatic Colorectal Cancer
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Neoplasms
Intervention  ICMJE Drug: 1018 ISS immunostimulatory oligonucleotide
6 weekly subcutaneous (under the skin) injections
Study Arms  ICMJE
  • Experimental: 1
    Low dose of 1018 ISS
    Intervention: Drug: 1018 ISS immunostimulatory oligonucleotide
  • Experimental: 2
    Middle dose of 1018 ISS
    Intervention: Drug: 1018 ISS immunostimulatory oligonucleotide
  • Experimental: 3
    High dose of 1018 ISS
    Intervention: Drug: 1018 ISS immunostimulatory oligonucleotide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 28, 2017)
14
Original Enrollment  ICMJE
 (submitted: November 21, 2006)
15
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00403052
Other Study ID Numbers  ICMJE DV2-ONC-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: 3/2017 No change in status of this study
Current Responsible Party Dynavax Technologies Corporation
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Dynavax Technologies Corporation
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Eduardo Martins, MD, DPhil Dynavax Technologies Corporation
PRS Account Dynavax Technologies Corporation
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP