Vaccine Therapy in Preventing Flu in Children With Acute Lymphoblastic Leukemia - Full Text View

Purpose

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.

Condition	Intervention
Infection Leukemia	Drug: trivalent influenza vaccine

MedlinePlus related topics:

Cancer Flu Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

ChemIDplus related topics:

Influenza Vaccines Fluvirin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care

Official Title:	Influenza Vaccine Immunogenicity in Children During and After Therapy for Acute Lymphoblastic Leukemia

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

August 2000

Detailed Description:

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

Ages Eligible for Study:	1 Year to 20 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00022035

Locations


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

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

Sponsors and Collaborators

Roswell Park Cancer Institute

National Cancer Institute (NCI)

Investigators


Study Chair:	Martin L. Brecher, MD	Roswell Park Cancer Institute

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000068742, RPCI-RP-9912, NCI-G01-1990
First Received:	August 10, 2001
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00022035
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

childhood acute lymphoblastic leukemia in remission

infection

Study placed in the following topic categories:

Lymphatic Diseases

Leukemia

Leukemia, Lymphoid

Immunoproliferative Disorders

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Influenza, Human

Lymphoproliferative Disorders

Lymphoma

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Immune System Diseases

Infection

ClinicalTrials.gov processed this record on September 05, 2008

Sponsors and Collaborators:	Roswell Park Cancer Institute National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00022035