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Sponsored by: |
Memorial Sloan-Kettering Cancer Center |
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Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00505063 |
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 |
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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 |
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 |
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 |
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A
Immunization Schedule patients <7 years.
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Biological: Immunization Schedule patients <7 years.
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B
Immunization Schedule patients > or = to 7 years and <11 years of age
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Biological: Immunization Schedule patients > or = to 7 years and <11 years of age
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C
Immunization Schedule patients > or = to 11 years of age
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Biological: Immunization Schedule patients > or = to 11 years of age
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To prospectively determine the response rate and duration of protective titers following revaccination with routine childhood immunizations in pediatric survivors of childhood cancer.
To develop standardized recommendations for the revaccination of children following cancer treatment which can be prospectively tested.
To determine whether in vitro parameters of lymphoid reconstitution correlate with response and duration of response.
Ages Eligible for Study: | 2 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patient must be 3 to 24months following completion of chemotherapy for malignant disease.
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)
Exclusion Criteria:
Contact: Trudy Small, MD | 212-639-5965 | smallt@mskcc.org |
Contact: Rachel Kobos, MD | 212-639-8451 | kobosr@mskcc.org |
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 |
Principal Investigator: | Trudy Small, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan Kettering Cancer Center ( Trudy Small, MD ) |
Study ID Numbers: | 07-088 |
Study First Received: | July 18, 2007 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00505063 |
Health Authority: | United States: Institutional Review Board |
vaccine childhood cancer |