Vaccine Therapy in Treating Patients With Non-Small Cell Lung Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00023985|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 7, 2011
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
RATIONALE: Vaccines made from a person's tumor cells and white blood cells may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have non-small cell lung cancer.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Biological: autologous tumor cell vaccine Biological: therapeutic autologous dendritic cells Procedure: conventional surgery||Phase 1|
- Determine the safety and feasibility of immunization with autologous tumor lysate-pulsed dendritic cell vaccine in patients with non-small cell lung cancer.
- Determine the immunologic response in patients treated with this vaccine.
OUTLINE: Patients undergo surgery to remove all or most of the gross evidence of tumor. Two months after surgery (or 4 months if chemotherapy and/or radiotherapy are required), patients undergo leukapheresis. Peripheral blood mononuclear cells are isolated and cultured with interleukin-4 and sargramostim (GM-CSF) to generate dendritic cells (DC). DC are then pulsed with tumor lysate prepared from previously removed tumor. Patients receive autologous tumor lysate-pulsed DC vaccine subcutaneously twice, 4 weeks apart.
Patients are followed every 4 months for 2 years, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Vaccination With Autologous Tumor Lysate-Pulsed Dendritic Cells - Phase I|
|Study Start Date :||January 2001|
|Actual Primary Completion Date :||July 2003|
|Actual Study Completion Date :||August 2003|
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Diagnosis of operable stage IB, II, or IIIA non-small cell lung cancer
- Tumor diameter of at least 3 cm
- 18 to 75
- ECOG 0-2
- At least 3 months
- WBC at least 3,000/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 2.0 mg/dL
- AST less than 2 times upper limit of normal (ULN)
- Lactate dehydrogenase less than 2 times ULN
- Hepatitis B and C negative
- Creatinine no greater than 1.4 mg/dL
- Positive cell mediated immunity test (i.e., greater than 5 mm induration in 48 hours with purified protein derivative (of tuberculin), candida, and mumps intradermal injection skin test)
- HIV negative
- No active systemic infection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- At least 4 weeks since prior biological materials
- At least 4 weeks since prior cytotoxic or chemotherapeutic agents
- Concurrent chemotherapy allowed after surgery and before vaccination
- No concurrent steroid therapy
- At least 4 weeks since prior radiotherapy
- Concurrent radiotherapy allowed after surgery and before vaccination
- See Disease Characteristics
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00023985
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Study Chair:||Timothy M. Anderson, MD||Roswell Park Cancer Institute|
|Responsible Party:||Timothy Anderson, MD, Roswell Park Cancer Institute|
|Other Study ID Numbers:||
|First Posted:||January 27, 2003 Key Record Dates|
|Last Update Posted:||March 7, 2011|
|Last Verified:||March 2011|
stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases