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Vaccine Therapy in Preventing Flu in Children With Acute Lymphoblastic Leukemia



Vaccine Therapy in Preventing Flu in Children With Acute Lymphoblastic Leukemia

For Condition: Infection,childhood acute lymphoblastic leukemia in remission
Status: Completed
Sponsor(s): Roswell Park Cancer Institute , National Cancer Institute (NCI)
Synopsis: RATIONALE: Flu vaccine may help the body build an immune response and decrease the occurrence of flu in children who are receiving chemotherapy for acute lymphoblastic leukemia. PURPOSE: Clinical trial to study the effectiveness of vaccine therapy in preventing flu in children who have acute lymphoblastic leukemia.
Details: OBJECTIVES: - Determine the immune response, in terms of the formation of protective antibody titers to influenza, in children with acute lymphoblastic leukemia treated with split-virus trivalent influenza vaccine. - Correlate the formation of protective antibody titers following immunization with the absolute neutrophil counts and absolute lymphocyte counts in these patients at the time of vaccination. OUTLINE: This is a multicenter study. Patients are stratified according to current treatment for acute lymphoblastic leukemia (consolidation chemotherapy vs maintenance chemotherapy vs off therapy for the past 6 months). Patients receive split-virus trivalent influenza vaccine intramuscularly once or twice at 4 weeks apart for 2 doses. Patients are followed at week 5. Patients receiving 2 doses of vaccine are also followed at week 9. PROJECTED ACCRUAL: A total of 175 patients (50 receiving consolidation therapy, 75 receiving maintenance therapy, and 50 off therapy) will be accrued for this study within 2 years.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 1 Year/20 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of acute lymphoblastic leukemia - In first remission after completion of induction chemotherapy - Currently on active treatment OR - Completed treatment within the past 6 months PATIENT CHARACTERISTICS: Age: - 1 to 20 at time of diagnosis Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Pulmonary: - No acute respiratory distress Other: - No history of Guillain-Barre syndrome - No history of hypersensitivity to chicken eggs, egg products, or components of influenza virus vaccine, including thimerosal - No febrile illness with fever over 100.4 degrees F - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - See Disease Characteristics Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified Other: - At least 7 days since prior antibiotic or antiviral therapy except prophylactic antibiotics
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
MartinBrecher,  Study Chair,  Roswell Park Cancer Institute

Hackensack University Medical Center
Hackensack,  New Jersey,  07601
United States
 

Roswell Park Cancer Institute
Buffalo,  New York,  14263-0001
United States
 


Additional Information:
Study ID Numbers:  CDR0000068742;  NCI-G01-1990,RPCI-RP-9912
Study Start Date: 
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00022035

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