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A Phase II Randomized Study of GM-CSF Gene-Modified Autologous Tumor Vaccine (CG8123) With and Without Low-Dose Cyclophosphamide in Advanced Stage Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer, Carcinoma, Non-Small-Cell Lung

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Trial Information

A Phase II Randomized Study of GM-CSF Gene-Modified Autologous Tumor Vaccine (CG8123) With and Without Low-Dose Cyclophosphamide in Advanced Stage Non-Small Cell Lung Cancer


Inclusion Criteria:



- 18 years or older

- Suspicious diagnosis of or histologically- confirmed stage IIIB or IV non small-cell
lung cancer

- Accessible and adequate tumor source for vaccine production.

- Tumor source for vaccine production must be accessible by a minor surgical procedure
performed under local or regional anesthesia (e.g. lymph node or soft tissue mass or
malignant pleural effusion)

- Measurable disease to evaluate following tumor procurement

- Limited metastatic tumor burden

- Life expectancy at least 4 months

- ECOG Performance Status 0 - 1

Exclusion Criteria:

- Active and/or untreated brain metastases

- Active or impending spinal cord compression

- Active auto-immune disease or treatment with immunosuppressants

- Decompensated congestive heart failure or recent significant cardiac event

- Coexisting malignancies

- Significant or uncontrolled medical problems or laboratory abnormalities that might
increase the risk of surgical complications or vaccine treatment

- Previous treatment with gene therapy (including any adenoviral-based therapy)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

D-0031

NCT ID:

NCT00089726

Start Date:

March 2003

Completion Date:

January 2006

Related Keywords:

  • Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • cancer vaccine
  • NSCLC
  • immunotherapy
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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