Clinical trial NCT00070629: CPG 7909 Injection in Non-Small Cell Lung Cancer
Official title: Promune™ (CPG 7909 Injection) In Combination With Chemotherapy In Patients With Advanced Or Metastatic Non-Small Cell Lung Cancer, A Randomized, Multi-Center, Controlled, Phase 2 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-Small Cell Lung
Keywords: Immunotherapy
lung cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2003-10-08
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Eligible patients will be randomized in a ratio of 2:1 to receive either chemotherapy (a taxane and a platinum compound) plus CPG 7909 Injection or chemotherapy alone. Protocol therapy will be administered until disease progression or intolerable toxicity. CpG 7909 Injection will be administered subcutaneously, on Weeks 2 and 3 of each three-week cycle (days 8 and 15) and chemotherapy will be administered on Week 1 (Day 1). Patients will undergo complete disease evaluation at the end of every other treatment cycle until disease progression.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed non-small cell lung cancer that is beyond surgical cure or that is metastatic (Stage IIIB or IV according to AJCC).
* Patients must have measurable disease according to the RECIST criteria.

Exclusion Criteria:

* Prior treatment with chemotherapy; patients may have received prior radiotherapy.
* Patients with suspected or known CNS metastases.

Primary outcomes:
measure: Efficacy- overall response rate (CR & PR) according to the RECIST criteria
timeFrame: Indeterminate
measure: Safety- drug exposure, adverse events, laboratory tests, vital signs, ECG, and physical examinations
timeFrame: Indeterminate
Secondary outcomes:
measure: Secondary Efficacy
timeFrame: Indeterminate
measure: compare number of patients who achieve complete response, partial response, or stable disease (CR, PR, SD) between the two treatment groups
timeFrame: Indeterminate
measure: duration of overall response (CR, PR), survival time, and time to disease progression.
timeFrame: Indeterminate
measure: To assess the immunopharmacodynamic response to CPG 7909 Injection plus chemotherapy in responding vs nonresponding patients receiving chemotherapy or the combination.
timeFrame: Indeterminate
Other outcomes:
Locations:
city: Gilroy
country: United States
facility: Office of Ronald Yanagihara
state: California
city: Los Angeles
country: United States
facility: Kenmar Research Institute, LLC
state: California
city: Palm Springs
country: United States
facility: Comprehensive Cancer Center of the Dessert
state: California
city: Fort Myers
country: United States
facility: Florida Cancer Specialist
state: Florida
city: Indianapolis
country: United States
facility: Indiana Hematology and Oncology Associates
state: Indiana
city: Vincennes
country: United States
facility: Medical Center Vincennes
state: Indiana
city: Hazard
country: United States
facility: Kentucky Cancer Clinic
state: Kentucky
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Lincoln
country: United States
facility: Southeast Nebraska Hematology Oncology Consultants, PC
state: Nebraska
city: East Orange
country: United States
facility: VA New Jersey Health Care System
state: New Jersey
city: Brooklyn
country: United States
facility: HemOnCare
state: New York
city: Asheville
country: United States
facility: Cancer Care of Western North Carolina
state: North Carolina
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Aiken
country: United States
facility: Cancer Care Institute of Carolina
state: South Carolina
city: Charleston
country: United States
facility: Charleston Hematology/Oncology, PA
state: South Carolina
city: Collierville
country: United States
facility: The Family Cancer Center
state: Tennessee
city: Marshfield
country: United States
facility: Marshfield Clinic
state: Wisconsin
city: Halifax
country: Canada
facility: Queen Elizabeth II Health
state: Nova Scotia
city: Ottawa
country: Canada
facility: Ottawa Regional Cancer Center
state: Ontario
city: Montreal
country: Canada
facility: McGill University
state: Quebec
city: Halle-Dolau
country: Germany
facility: Staedtisches Krankenhaus Martha-Maria
city: Heidelberg
country: Germany
facility: Universitätsklinikum Mannheim der Universität Heidelberg
city: Karlsruhe
country: Germany
facility: St. Vincentius-Kliniken gAG, Hamatologie-Onkologie
city: Munchen
country: Germany
facility: Klinikum Rechts der Isar
Study officials:
References: