Prospective Trial of Vaccine Responses in Childhood Cancer Survivors - Full Text View

Purpose

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	Intervention	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 Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Prospective Trial of Vaccine Responses in Childhood Cancer Survivors

Resource links provided by NLM:

MedlinePlus related topics: Cancer Chickenpox Measles Mumps Rubella

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Meningococcal Vaccines Pneumococcal Vaccines Chickenpox Vaccine

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

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. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	75
Study Start Date:	July 2007
Estimated Study Completion Date:	July 2014
Estimated Primary Completion Date:	July 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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
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
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)

Eligibility

Ages Eligible for Study:	2 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00505063

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center 1275 York Avenue
New York, New York, United States, 10021

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

Trudy Small, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00505063 History of Changes
Other Study ID Numbers:	07-088
Study First Received:	July 18, 2007
Last Updated:	March 1, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

vaccine
childhood
cancer

ClinicalTrials.gov processed this record on May 22, 2013