Immunization Response for Childhood Cancer Survivors

Palo Alto (17 mi)

Overseen byNancy Kernan, MD

Age: < 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for childhood cancer survivors aged 3 to 24 months post-chemotherapy, under 18 at diagnosis. They must be in remission with no active infections or HIV, not pregnant or breastfeeding, and able to consent. Excluded are those with low Karnofsky scores, prior stem cell transplants, vaccine allergies, on immunosuppressants, allergic to latex or who've had Rituximab.

Inclusion Criteria

Remission criteria for different cancer types: 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)

I finished my chemotherapy for cancer between 3 to 24 months ago.

I achieved complete remission within 3 months of finishing my therapy, which ended less than a year ago.

I was diagnosed with cancer before turning 18.

Exclusion Criteria

I am HIV positive.

My health status is below 70% on the Karnofsky scale.

I have had a stem cell transplant from myself or a donor.

I am currently pregnant or breastfeeding.

I do not have an ongoing severe infection.

I am currently taking medication that suppresses my immune system.

I have received Rituximab treatment.

Treatment Details

The study tests how well new vaccination schedules work for young cancer survivors of different age groups: below 7 years old; between 7 and less than 11 years old; and those aged 11 and above. It aims to establish a standard re-immunization process against diseases like measles.

3Treatment groups

Experimental Treatment

Group I: CExperimental Treatment1 Intervention

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

Group II: BExperimental Treatment1 Intervention

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

Group III: AExperimental Treatment1 Intervention

Immunization Schedule patients \<7 years.