Prospective Trial of Vaccine Responses in Childhood Cancer Survivors

August 29, 2023 updated by: Memorial Sloan Kettering Cancer Center

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
conclusion of study

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine whether in vitro parameters of lymphoid reconstitution correlate with response and duration of response.
Time Frame: conclusion of study
conclusion of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Nancy Kernan, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

July 18, 2007

First Submitted That Met QC Criteria

July 19, 2007

First Posted (Estimated)

July 20, 2007

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-088

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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