Phase II Trial of CG8123, an Autologous Cancer Vaccine (GVAX), in Patients With Selected Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC)
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- SWOG Cancer Research Network
- Enrollment
- 19
- Primary Endpoint
- Functional status
Study Overview
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 Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
treatment
GVAX lung cancer vaccine
Intervention: GVAX lung cancer vaccine (Biological)
Outcomes
Primary Outcomes
Functional status
Toxicity
Progression-free and overall survival
Correlation of systemic biologic activity with clinical outcome
Response rate
Secondary Outcomes
No secondary outcomes reported