Clinical trial NCT00403052: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Colorectal Neoplasms
Keywords: colorectal
cancer
carcinoma
metastatic
colon
rectal
neoplasm
cetuximab
irinotecan
1018 ISS
combination therapy
Lead sponsor: Dynavax Technologies Corporation
Sponsor class: INDUSTRY
First posted: 2006-11-23
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Occurrence of adverse events
timeFrame: 16 weeks
Secondary outcomes:
measure: Time to tumor progression
timeFrame: 9 or more weeks
measure: Overall survival time
timeFrame: 9 or more weeks
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Premiere Oncology
state: California
city: Washington
country: United States
facility: Lombardi Comprehensive Cancer Center, Georgetown University
state: District of Columbia
city: Bethesda
country: United States
facility: Center for Cancer and Blood Disorders
state: Maryland
Study officials:
affiliation: Dynavax Technologies Corporation
name: Eduardo Martins, MD, DPhil
role: STUDY_DIRECTOR
References: