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Sponsored by: |
Dynavax Technologies Corporation |
Information provided by: | Dynavax Technologies Corporation |
ClinicalTrials.gov Identifier: | NCT00403052 |
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 | Intervention | Phase |
Colorectal Neoplasms |
Drug: 1018 ISS immunostimulatory oligonucleotide |
Phase I |
MedlinePlus related topics: | Cancer Colorectal Cancer |
ChemIDplus related topics: | Irinotecan Irinotecan hydrochloride Bevacizumab Oxaliplatin Cetuximab |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 15 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | March 2008 |
Arms | Assigned Interventions |
1: Experimental
Low dose of 1018 ISS
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Drug: 1018 ISS immunostimulatory oligonucleotide
6 weekly subcutaneous (under the skin) injections
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2: Experimental
Middle dose of 1018 ISS
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Drug: 1018 ISS immunostimulatory oligonucleotide
6 weekly subcutaneous (under the skin) injections
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3: Experimental
High dose of 1018 ISS
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Drug: 1018 ISS immunostimulatory oligonucleotide
6 weekly subcutaneous (under the skin) injections
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Dynavax Technologies Corporation |
Study Director: | Eduardo Martins, MD, DPhil | Dynavax Technologies Corporation |
Dynavax Webpage 
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Study ID Numbers: | DV2-ONC-01 |
First Received: | November 21, 2006 |
Last Updated: | November 1, 2007 |
ClinicalTrials.gov Identifier: | NCT00403052 |
Health Authority: | United States: Food and Drug Administration |
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