Know Cancer

forgot password

Phase II Prospective Trial of Vaccine Responses in Childhood Cancer Survivors

Phase 2
2 Years
18 Years
Open (Enrolling)
Childhood Cancer, Multiple Diseases

Thank you

Trial Information

Phase II Prospective Trial of Vaccine Responses in Childhood Cancer Survivors

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

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To prospectively determine the response rate and duration of protective titers following revaccination with routine childhood immunizations in pediatric survivors of childhood cancer.

Outcome Time Frame:

conclusion of study

Safety Issue:


Principal Investigator

Trudy Small, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

July 2007

Completion Date:

July 2014

Related Keywords:

  • Childhood Cancer
  • Multiple Diseases
  • vaccine
  • childhood
  • cancer



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