Full Text View
Tabular View
No Study Results Posted
Related Studies
Prospective Trial of Vaccine Responses in Childhood Cancer Survivors
This study is currently recruiting participants.
Verified by Memorial Sloan-Kettering Cancer Center, April 2009
First Received: July 18, 2007   Last Updated: April 23, 2009   History of Changes
Sponsored by: Memorial Sloan-Kettering Cancer Center
Information provided by: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00505063
  Purpose

This study will look at your body's response to the new immunizations. We want to see how well they will protect you. Immunization is the same as vaccination. Our goal is to protect you as much as we can. We do not want you to have the measles, mumps, or whooping cough. We are doing the study because there is no standard way to re-immunize people after cancer treatments.


Condition Intervention Phase
Childhood Cancer
Multiple Diseases
Biological: Immunization Schedule patients <7 years.
Biological: Immunization Schedule patients > or = to 7 years and <11 years of age
Biological: Immunization Schedule patients > or = to 11 years of age
Phase II

MedlinePlus related topics: Cancer Childhood Immunization Measles Mumps Rubella
Drug Information available for: Heptavalent pneumococcal conjugate vaccine Meningococcal Vaccines Pneumococcal Vaccines Chickenpox Vaccine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Phase II Prospective Trial of Vaccine Responses in Childhood Cancer Survivors

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To prospectively determine the response rate and duration of protective titers following revaccination with routine childhood immunizations in pediatric survivors of childhood cancer. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine whether in vitro parameters of lymphoid reconstitution correlate with response and duration of response. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: July 2007
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A
Immunization Schedule patients <7 years.
Biological: Immunization Schedule patients <7 years.
  • Time 0 months: Prevnar #1, Hib #1
  • Time 1 months: Pediarix #1
  • Time 2 months: Prevnar #2, Hib #2
  • Time 3-4 months: Pediarix #2
  • Time 4-6 months: Draw post vaccine titers
  • Time 6-12 months: Administer Hepatitis #3 to patients not immunized prior to treatment for cancer, or with negative Hepatitis B titers after two immunizations.
B
Immunization Schedule patients > or = to 7 years and <11 years of age
Biological: Immunization Schedule patients > or = to 7 years and <11 years of age
  • Time 0 months: Hib #1, Prevnar #1, Hepatitis B #1
  • Time 1 month: Td#1, IPV #1(inactivated polio virus vaccine), Hepatitis B #2
  • Time 2-3 months: Prevnar #2, Hib #2
  • Time 3-6 months: Td #2, Draw post vaccine titers Time 6-12 months: Administer Hepatitis #3 to patients not immunized prior to treatment for cancer, or with negative Hepatitis B titers after two immunizations.
C
Immunization Schedule patients > or = to 11 years of age
Biological: Immunization Schedule patients > or = to 11 years of age
  • Time 0 month: Hib#1, Prevnar #1, Hepatitis B #1
  • Time 1 month: Tdap, Hepatitis B #2
  • Time 2-3 months: Hib #2, Prevnar #2, Menactra
  • Time 3-6 months: IPV, Draw post vaccine titers
  • Time 6-12 months: Gardasil (dose #2 given 2 months after first dose, and dose #3 given 6 months after first dose)

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient must be <18 years of age at cancer diagnosis
  • Patient must be 3 to 24months following completion of chemotherapy for malignant disease.

    1. For patients <12 months following completion of therapy, CR must be documented within 3 months of enrollment.
    2. For patients >12 months, CR must be documented at approximately 12 months and then only as clinically indicated

    i. For patients with leukemia: bone marrow aspirate defined as <5% blasts, absence of cytogenetic abnormality by FISH or karyotype (if applicable) and no evidence of CSF involvement (if applicable) ii. For patients with solid tumors remission will be determined by appropriate radiologic scans, and other tests, including bone marrow aspirate and biopsies demonstrating absence of extrinsic cells and absence of specific FISH or cytogenetic abnormality (if applicable), iii. For patients with lymphoma, remission will be determined by bone marrow aspirate and biopsy, radiologic scans and other tests. Bone marrow will show <5% blasts, absence of cytogenetic abnormality by FISH or karyotype (if applicable), and flow cytometry (if lymphoma specific marker present) and absence of CNS disease by spinal fluid (if applicable)

  • Patient may be of either gender and of any ethnic background
  • Patients or their guardians must be able to understand the nature and risk of the proposed study and be able to sign consent.

Exclusion Criteria:

  • Karnofsky score <70%.
  • Female patients who are pregnant or lactating.
  • Patients who have received an autologous or allogeneic HCT.
  • Active uncontrolled bacterial or fungal infection.
  • Patients who have a history of previous allergic reaction to vaccinations currently recommended by the ACIP.
  • Patients on any immunosuppressive drugs.
  • HIV-1,2 sero-positive patients.
  • Patients or guardians not signing informed consent.
  • Patients with prior allergic reaction to any vaccine component or to latex.
  • Patients who have received Rituximab.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00505063

Contacts
Contact: Trudy Small, MD 212-639-5965 smallt@mskcc.org
Contact: Rachel Kobos, MD 212-639-8451 kobosr@mskcc.org

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center 1275 York Avenue Recruiting
New York, New York, United States, 10021
Contact: Trudy Small, MD     212-639-5965     smallt@mskcc.org    
Principal Investigator: Trudy Small, MD            
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Trudy Small, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan Kettering Cancer Center ( Trudy Small, MD )
Study ID Numbers: 07-088
Study First Received: July 18, 2007
Last Updated: April 23, 2009
ClinicalTrials.gov Identifier: NCT00505063     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
vaccine
childhood
cancer

ClinicalTrials.gov processed this record on May 06, 2009