Clinical Trial: CPG 7909 Injection in non-small cell lung cancer

This study is no longer recruiting patients.

Sponsored by: Coley Pharmaceutical Group
Information provided by: Coley Pharmaceutical Group

Purpose

This is a randomized, multi-center, Phase 2 trial comparing treatment with CPG 7909 Injection plus chemotherapy or chemotherapy alone in patients with non-small cell lung cancer (NSCLC).

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.

Patients will remain on study until the development of objective tumor progression.

Condition Treatment or Intervention Phase
Carcinoma, Non-Small-Cell Lung
 Drug: Standard Platinum and Taxane Chemotherapy
 Drug: CpG 7909
Phase II

MedlinePlus related topics:  Cancer;   Lung Cancer

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title: 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

Further Study Details: 

Expected Total Enrollment:  112

Study start: April 2003

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

Exclusion Criteria:

  • Patients with active infection or with a fever >38.50 C within three days prior to the first scheduled day of dosing
  • Prior treatment with chemotherapy; patients may have received prior radiotherapy
  • Patients with suspected or known CNS metastases
  • Prior treatment with etanercept, anakinra, leflunomide, or tacrolimus for any reason
  • The need for pharmacologic doses of systemic steroids will be excluded; replacement doses, topical or inhalation glucocorticoids are permitted.
  • Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren’s syndrome, autoimmune thrombocytopenia, etc.
  • Chloroquine and related compounds within 12 weeks of study entry (1st dose of protocol therapy)
  • History of other prior malignancy within the past 5 years other than basal cell carcinoma of the skin or cervical intra-epithelial neoplasia, or cured, early prostate cancer in a patient with PSA < 10 ng/mL
  • Patients with known hypersensitivity to any of the components of CpG 7909 Injection or to any of the components of the taxane or platinum drugs
  • Patients who have received an investigational therapy within 30 days of study entry (1st dose of protocol therapy)
  • Serious medical or psychiatric condition, which would hinder the patient’s ability to fully comply with the protocol
  • Grade 2 peripheral neuropathy
  • Patients who are pregnant or lactating
  • Adults of reproductive potential and their partners must agree to use effective contraceptive measures
  • History of allogeneic transplant
  • Known HIV
  • Treatment with hematopoietic growth factors within 4 weeks of the first CpG 7909 Injection

Location Information


California
      Comprehensive Cancer Center of the Dessert, Palm Springs,  California,  92262,  United States

      Kenmar Research Institute, LLC, Los Angeles,  California,  90057,  United States

      9360 No Name Uno, Gilroy,  California,  95020,  United States

Florida
      Florida Cancer Specialist, Fort Myers,  Florida,  33901,  United States

Minnesota
      University of Minnesota, Minneapolis,  Minnesota,  55455,  United States

New Jersey
      VA New Jersey Health Care System, East Orange,  New Jersey,  07018,  United States

New York
      HemOnCare, Brooklyn,  New York,  11212,  United States

Oregon
      Providence Portland Medical Center, Portland,  Oregon,  97213,  United States

South Carolina
      Charleston Hematology/Oncology, PA, Charleston,  South Carolina,  29403,  United States

Tennessee
      The Family Cancer Center, Collierville,  Tennessee,  38017,  United States

Wisconsin
      Marshfield Clinic, Marshfield,  Wisconsin,  54449,  United States

Canada, Nova Scotia
      Queen Elizabeth II Health, Halifax,  Nova Scotia,  B3H 1V7,  Canada

Canada, Ontario
      Ottawa Regional Cancer Center, Ottawa,  Ontario,  K1H 1C4,  Canada

Canada, Quebec
      McGill University, Montreal,  Quebec,  H2W 1S6,  Canada

Germany
      Thoraxklinik-Heidelberg GmbH, Heidelberg,  Germany

      Staedtisches Krankenhaus Martha-Maria, Halle-Dolau,  D-06120,  Germany

More Information

Study ID Numbers:  C017; ProMune
Record last reviewed:  October 2004
Last Updated:  October 13, 2004
Record first received:  October 6, 2003
ClinicalTrials.gov Identifier:  NCT00070629
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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