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Prospective Trial of Vaccine Responses in Childhood Cancer Survivors
This study is currently recruiting participants.
Study NCT00505063   Information provided by Memorial Sloan-Kettering Cancer Center
First Received: July 18, 2007   Last Updated: April 23, 2009   History of Changes
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July 18, 2007
April 23, 2009
July 2007
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 ]
Same as current
Complete list of historical versions of study NCT00505063 on ClinicalTrials.gov Archive Site
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 ]
Same as current
 
Prospective Trial of Vaccine Responses in Childhood Cancer Survivors
Phase II Prospective Trial of Vaccine Responses in Childhood Cancer Survivors

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.

 
Phase II
Interventional
Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
  • 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
  • Other: Immunization Schedule patients <7 years.
  • Other: Immunization Schedule patients > or = to 7 years and <11 years of age
  • Other: Immunization Schedule patients > or = to 11 years of age
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
75
July 2010
July 2010   (final data collection date for primary outcome measure)

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.
Both
2 Years to 18 Years
No
Contact: Trudy Small, MD 212-639-5965 smallt@mskcc.org
Contact: Rachel Kobos, MD 212-639-8451 kobosr@mskcc.org
United States
 
 
NCT00505063
Trudy Small, MD, Memorial Sloan Kettering Cancer Center
 
Memorial Sloan-Kettering Cancer Center
 
Principal Investigator: Trudy Small, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
April 2009

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.