Prospective Trial of Vaccine Responses in Childhood Cancer Survivors

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Active, not recruiting; Phase 2

Conditions: Childhood Cancer; Multiple Diseases

Treatments: Biological: Immunization Schedule patients <7 years.; Biological: Immunization Schedule patients > or = to 11 years of age; Biological: Immunization Schedule patients > or = to 7 years and <11 years of age

Study type: Interventional

Funder types: Other

Identifiers

NCT00505063

07-088

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No 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.

  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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

A

Other group

Description:

Immunization Schedule patients \<7 years.

Treatment:

Biological: Immunization Schedule patients <7 years.

B

Other group

Description:

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

Treatment:

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

C

Other group

Description:

Immunization Schedule patients \> or = to 11 years of age

Treatment:

Biological: Immunization Schedule patients > or = to 11 years of age