NCT00403052

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 23, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

1.1 years

First QC Date

November 21, 2006

Last Update Submit

April 11, 2019

Conditions

Colorectal Neoplasms

Keywords

colorectalcancercarcinomametastaticcolonrectalneoplasmcetuximabirinotecan1018 ISScombination therapy

Outcome Measures

Primary Outcomes (1)

  • Occurrence of adverse events

    16 weeks

Secondary Outcomes (2)

  • Time to tumor progression

    9 or more weeks

  • Overall survival time

    9 or more weeks

Study Arms (3)

1

EXPERIMENTAL

Low dose of 1018 ISS

Drug: 1018 ISS immunostimulatory oligonucleotide

2

EXPERIMENTAL

Middle dose of 1018 ISS

Drug: 1018 ISS immunostimulatory oligonucleotide

3

EXPERIMENTAL

High dose of 1018 ISS

Drug: 1018 ISS immunostimulatory oligonucleotide

Interventions

1018 ISS immunostimulatory oligonucleotideDRUG

6 weekly subcutaneous (under the skin) injections

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Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Premiere Oncology

Santa Monica, California, 90404, United States

Location

Lombardi Comprehensive Cancer Center, Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

Center for Cancer and Blood Disorders

Bethesda, Maryland, 20817, United States

Location

Related Links

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasmsCarcinomaNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Eduardo Martins, MD, DPhil

    Dynavax Technologies Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2006

First Posted

November 23, 2006

Study Start

November 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

April 16, 2019

Record last verified: 2019-04

Locations

US(3)