Clinical Trial: S0310: Vaccine Therapy in Treating Patients With Stage IIIB or Stage IV Bronchoalveolar Lung Cancer

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Phase II Trial of CG8123, an Autologous Cancer Vaccine (GVAX), in Patients With Selected Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC)

Brief Summary:

RATIONALE: Vaccines made from a person's tumor tissue may make the body build an immune response to kill tumor cells.

PURPOSE: This phase II trial is studying vaccine therapy to see how well it works in treating patients with stage IIIB or stage IV bronchoalveolar (lung) cancer.


Detailed Summary:

OBJECTIVES:

  • Determine the progression-free and overall survival of patients with selected stage IIIB or stage IV bronchoalveolar carcinoma treated with GVAX lung cancer vaccine.
  • Determine the response rate (confirmed and unconfirmed and complete and partial) in patients treated with this vaccine.
  • Determine the frequency and severity of toxic effects of this vaccine in these patients.
  • Determine the functional status of patients treated with this vaccine.
  • Correlate systemic biologic activity (i.e., antigen-specific antitumor and systemic cytokine responses) with clinical outcome in patients treated with this vaccine.

OUTLINE: This is a multicenter study. Patients are stratified according to prior systemic cancer therapy for bronchoalveolar carcinoma (BAC) (yes vs no) and pattern of BAC (diffuse vs nodular).

After successful vaccine manufacturing from tumor tissue procured, patients receive GVAX lung cancer vaccine intradermally (ID) (6-7 injections per vaccination) on weeks 1, 3, 5, 7, and 9 for a total of 5 vaccinations. Treatment continues in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and at weeks 9, 13, and 21.

Patients are followed at 4 weeks, every 8 weeks for 1 year, and then every 12 weeks for 2 years.

PROJECTED ACCRUAL: A total of 117 patients (67 previously untreated and 50 previously treated) will be accrued for this study.


Sponsor: Southwest Oncology Group

Current Primary Outcome:

  • Progression-free and overall survival
  • Response rate
  • Toxicity
  • Functional status
  • Correlation of systemic biologic activity with clinical outcome


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Southwest Oncology Group

Dates:
Date Received: December 10, 2003
Date Started: March 2004
Date Completion:
Last Updated: July 20, 2012
Last Verified: July 2012