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Sponsors and Collaborators: |
Barbara Ann Karmanos Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004019 |
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of biological therapy following surgery and chemotherapy in treating patients who have stage II, stage III, or stage IV lung cancer.
Condition | Intervention | Phase |
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Lung Cancer |
Biological: aldesleukin Biological: autologous tumor cell vaccine Biological: muromonab-CD3 Biological: therapeutic autologous lymphocytes Drug: chemotherapy Procedure: surgical procedure |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Immunotherapy for Lung Carcinoma - Phase II Trial of Autologous Cancer Antigen Specific Immunotherapy |
Study Start Date: | June 1997 |
Primary Completion Date: | January 2004 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients are stratified according to extent of disease, extent of antigen specific response to vaccination, performance status (0 vs 1), prior therapy (yes vs no), and gender.
Patients undergo surgical debulking of tumor on week 1 followed by adjuvant chemotherapy. Within 2-4 weeks of chemotherapy, patients are vaccinated with irradiated autologous tumor cells and sargramostim (GM-CSF), then receive GM-CSF alone intradermally at vaccination sites daily for 4 days. Patients are revaccinated 2 weeks later.
Patients undergo peripheral blood mononuclear cell collection two weeks after the second vaccination. Peripheral blood mononuclear cells are stimulated with anti-CD3 monoclonal antibody (OKT3) and interleukin-2, producing activated T lymphocytes. The activated T lymphocytes are infused IV over 1-6 hours followed by 5 doses of interleukin-2 IV every other day over 10 days. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients may receive one additional course of immunotherapy as above.
Patients are followed every 3 months for 2 years, then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven stage II, III, or IV lung cancer
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | |
Detroit, Michigan, United States, 48201 |
Study Chair: | Roy D. Baynes, MD, PhD, FACP | Barbara Ann Karmanos Cancer Institute |
Study ID Numbers: | CDR0000067238, WSU-C-1403-LU, NCI-G99-1562 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00004019 History of Changes |
Health Authority: | United States: Federal Government |
stage II non-small cell lung cancer recurrent non-small cell lung cancer limited stage small cell lung cancer extensive stage small cell lung cancer |
recurrent small cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
Thoracic Neoplasms Anti-HIV Agents Immunologic Factors Antiviral Agents Immunosuppressive Agents Recurrence Carcinoma Muromonab-CD3 |
Carcinoma, Small Cell Aldesleukin Anti-Retroviral Agents Respiratory Tract Diseases Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung |
Thoracic Neoplasms Anti-Infective Agents Respiratory Tract Neoplasms Anti-HIV Agents Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Antiviral Agents Immunosuppressive Agents Pharmacologic Actions |
Muromonab-CD3 Neoplasms Neoplasms by Site Aldesleukin Anti-Retroviral Agents Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases |