Overview

This trial is active, not recruiting.

Conditions childhood cancer, multiple diseases
Treatments immunization schedule patients <7 years., immunization schedule patients > or = to 7 years and <11 years of age, immunization schedule patients > or = to 11 years of age
Phase phase 2
Sponsor Memorial Sloan Kettering Cancer Center
Start date July 2007
End date July 2016
Trial size 75 participants
Trial identifier NCT00505063, 07-088

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Immunization Schedule patients <7 years.
immunization schedule patients <7 years. vaccine, Prevnar 13
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)
Immunization Schedule patients > or = to 7 years and <11 years of age
immunization schedule patients > or = to 7 years and <11 years of age vaccine, Prevnar 13
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)
Immunization Schedule patients > or = to 11 years of age
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)

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
To determine whether in vitro parameters of lymphoid reconstitution correlate with response and duration of response.
time frame: conclusion of study

Eligibility Criteria

Male or female participants from 2 years up to 18 years old.

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.

Additional Information

Official title Phase II Prospective Trial of Vaccine Responses in Childhood Cancer Survivors
Principal investigator Rachel Kobos, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.