Prospective Trial of Vaccine Responses in Childhood Cancer Survivors

Childhood Cancer Clinical Trial

Official title:

Phase II Prospective Trial of Vaccine Responses in Childhood Cancer Survivors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00505063
• Other study ID #: 07-088
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 2007
• Est. completion date: July 2024

Study information

• Verified date: August 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Childhood Cancer
• Multiple Diseases

Intervention

Biological:
• Immunization Schedule patients <7 years.
Time 0 months: Prevnar 13 #1, Hib #1 Time 1 months: Pediarix #1 Time 2 months: Prevnar 13 #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.
• Immunization Schedule patients > or = to 7 years and <11 years of age
Time 0 months: Hib #1, Prevnar 13 #1, Hepatitis B #1 Time 1 month: Td#1, IPV #1(inactivated polio virus vaccine), Hepatitis B #2 Time 2-3 months: Prevnar 13 #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.
• Immunization Schedule patients > or = to 11 years of age
Time 0 month: Hib#1, Prevnar 13#1, Hepatitis B #1 Time 1 month: Tdap(BOOSTRIX), Hepatitis B #2 Time 2-3 months: Hib #2, Prevnar 13#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)

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center 1275 York Avenue	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To prospectively determine the response rate and duration of protective titers following revaccination with routine childhood immunizations in pediatric survivors of childhood cancer.		conclusion of study
Secondary	To determine whether in vitro parameters of lymphoid reconstitution correlate with response and duration of response.		conclusion of study

External Links

•   Memorial Sloan-Kettering Cancer Center