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 |
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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. |
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Phase II |
Interventional |
Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
- Childhood Cancer
- Multiple Diseases
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- 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
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- 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
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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.
- For patients <12 months following completion of therapy, CR must be documented within 3 months of enrollment.
- 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.
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Both |
2 Years to 18 Years |
No |
|
United States |
|
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NCT00505063 |
Trudy Small, MD, Memorial Sloan Kettering Cancer Center |
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Memorial Sloan-Kettering Cancer Center |
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Principal Investigator: |
Trudy Small, MD |
Memorial Sloan-Kettering Cancer Center |
|
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Memorial Sloan-Kettering Cancer Center |
April 2009 |