Prospective Trial of Vaccine Responses in Childhood Cancer Survivors
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 2 - 18 |
| Updated: | 8/4/2018 |
| Start Date: | July 2007 |
| End Date: | July 2019 |
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.
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.
Inclusion Criteria:
- Patient must be < or less 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.
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