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

• ClinicalTrials.gov Identifier: NCT00403052
• Recruitment Status: Terminated
• First Posted: November 23, 2006
• Last Update Posted: April 16, 2019
• Sponsor: Dynavax Technologies Corporation
• Information provided by (Responsible Party): Dynavax Technologies Corporation

Tracking Information

• First Submitted Date: November 21, 2006
• First Posted Date: November 23, 2006
• Last Update Posted Date: April 16, 2019
• Study Start Date: November 2006
• Actual Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 1, 2007): Occurrence of adverse events [ Time Frame: 16 weeks ]
• Original Primary Outcome Measures (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.

Current Secondary Outcome Measures (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: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Colorectal Neoplasms

Intervention

Drug: 1018 ISS immunostimulatory oligonucleotide

6 weekly subcutaneous (under the skin) injections

Study Arms

• 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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: August 28, 2017): 14
• Original Enrollment (submitted: November 21, 2006): 15
• Actual Study Completion Date: December 2007
• Actual Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00403052
• Other Study ID Numbers: DV2-ONC-01
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• 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: Dynavax Technologies Corporation
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Eduardo Martins, MD, DPhil; Dynavax Technologies Corporation

• PRS Account: Dynavax Technologies Corporation
• Verification Date: April 2019