Vaccine Therapy Plus QS21 in Treating Patients With Small Cell Lung Cancer That Has Responded to Initial Therapy
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|ClinicalTrials.gov Identifier: NCT00004249|
Recruitment Status : Completed
First Posted : April 28, 2004
Last Update Posted : June 19, 2013
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Biological therapies, such as QS21, use different ways to stimulate the immune system and stop cancer cells from growing.
PURPOSE: Phase II trial to study the effectiveness of vaccine therapy plus QS21 in treating patients who have small cell lung cancer that has responded to initial therapy.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Biological: QS21 Biological: keyhole limpet hemocyanin Drug: polysialic acid||Phase 2|
OBJECTIVES: I. Compare the antibody response after immunization with polysialic acid keyhole limpet hemocyanin (PSA-KLH) conjugate or N-propionylated PSA-KLH conjugate plus immunological adjuvant QS21 in patients with small cell lung cancer. II. Assess the clinical toxicities resulting from these regimens and from the immune response in this patient population.
OUTLINE: Patients receive polysialic acid keyhole limpet hemocyanin (PSA-KLH) conjugate or N-propionylated PSA-KLH conjugate plus immunological adjuvant QS21 subcutaneously weekly on weeks 1-4 and on weeks 8 and 16 for a total of 6 vaccinations. Patients are followed at 2 weeks, and then every 3 months for up to 1 year.
PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Immunization Using Polysialic Acid-KLH or N-Propionylated Polysialic Acid-KLH Conjugate Plus the Immunological Adjuvant QS-21 in Patients With Small Cell Lung Cancer Who Have Achieved a Major Response to Initial Therapy|
|Study Start Date :||August 1998|
|Actual Primary Completion Date :||November 2001|
|Actual Study Completion Date :||November 2001|
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): NCT00004249
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Lee M. Krug, MD||Memorial Sloan Kettering Cancer Center|