Prospective Trial of Vaccine Responses in Childhood Cancer Survivors

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT00505063

Collaborator

(none)

Enrollment

Location

Arms

192

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
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 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase II Prospective Trial of Vaccine Responses in Childhood Cancer Survivors

Study Start Date :

Jul 1, 2007

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: A Immunization Schedule patients <7 years.	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. Other Names: vaccine, Prevnar 13 vaccine, Menactra II Measles, mumps, rubella, MMR Live, attenuated varicella vaccine, Varivax Quadrivalent HPV Recombinant Vaccine
Other: B Immunization Schedule patients > or = to 7 years and <11 years of age	Biological: 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. Other Names: vaccine, Prevnar 13 vaccine, Menactra II Measles, mumps, rubella, MMR Live, attenuated varicella vaccine, Varivax Quadrivalent HPV Recombinant Vaccine
Other: C Immunization Schedule patients > or = to 11 years of age	Biological: 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)

Arm

Intervention/Treatment

Other: A

Immunization Schedule patients <7 years.

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.

Other Names:

vaccine, Prevnar 13

vaccine, Menactra II

Measles, mumps, rubella, MMR

Live, attenuated varicella vaccine, Varivax

Quadrivalent HPV Recombinant Vaccine

Other: B

Immunization Schedule patients > or = to 7 years and <11 years of age

Biological: 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.

Other Names:

vaccine, Prevnar 13

vaccine, Menactra II

Measles, mumps, rubella, MMR

Live, attenuated varicella vaccine, Varivax

Quadrivalent HPV Recombinant Vaccine

Other: C

Immunization Schedule patients > or = to 11 years of age

Biological: 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)

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

To determine whether in vitro parameters of lymphoid reconstitution correlate with response and duration of response. [conclusion of study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

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

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.