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Vaccine Therapy Plus QS21 in Treating Patients With Small Cell Lung Cancer That Has Responded to Initial Therapy



Vaccine Therapy Plus QS21 in Treating Patients With Small Cell Lung Cancer That Has Responded to Initial Therapy

For Condition: limited stage small cell lung cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed small cell lung cancer - Must have completed initial therapy with or without radiotherapy and have achieved a complete response or partial response to therapy without subsequent evidence of disease progression; Must have completed any radiotherapy including prophylactic cranial radiotherapy as part of the planned primary therapy --Prior/Concurrent Therapy-- - Biologic therapy: See Disease Characteristics; At least 4 weeks but no more than 12 weeks since prior initial therapy and recovered - Chemotherapy: See Disease Characteristics; At least 4 weeks but no more than 12 weeks since prior initial therapy and recovered - Endocrine therapy: See Disease Characteristics; At least 4 weeks but no more than 12 weeks since prior initial therapy and recovered; No concurrent corticosteroids - Radiotherapy: See Disease Characteristics; At least 4 weeks but no more than 12 weeks since prior initial therapy and recovered; No prior radiotherapy to the spleen - Surgery: No prior splenectomy --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 70-100% - Life expectancy: Not specified - Hematopoietic: WBC at least 3,000/mm3; Lymphocyte count at least 500/mm3 - Hepatic: Bilirubin no greater than 1.5 mg/dL; SGOT no greater than 1.5 times upper limit of normal (ULN); Alkaline phosphatase no greater than 1.5 times ULN - Renal: Not specified - Cardiovascular: No New York Heart Association class III or IV heart disease - Other: No known immunodeficiency or autoimmune disease; No other active malignancies within the past 5 years except nonmelanoma skin cancer; No clinically significant peripheral neuropathy; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
KennethNg,  Study Chair,  Memorial Sloan-Kettering Cancer Center

Memorial Sloan-Kettering Cancer Center
New York City,  New York,  10021
United States
 


Additional Information:
Study ID Numbers:  CDR0000067495;  MSKCC-98065,NCI-H99-0047
Study Start Date: August 1998
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004249

Other Limited Stage Small Cell Lung Cancer Studies:
1. Topotecan in Treating Patients With Relapsed Small Cell Lung Cancer

2. Fenretinide in Treating Patients With Recurrent Small Cell Lung Cancer

3. Photodynamic Therapy Plus Brachytherapy in Treating Patients With Lung Cancer

4. Megestrol in Treating Patients Who Are Undergoing Radiation Therapy for Lung Cancer

5. Neoadjuvant Chemoradiotherapy Followed By Surgery in Treating Patients With Limited-Stage Small Cell Lung Cancer

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