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Cancer Vaccine

Immunization Response for Childhood Cancer Survivors

Phase 2
Waitlist Available
Led By Nancy Kernan, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Patient must be 3 to 24 months following completion of chemotherapy for malignant disease
Must not have
HIV-1,2 sero-positive patients
Karnofsky score <70%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved

Summary

This trial will study how well cancer patients' bodies respond to new immunizations. The goal is to see how well the immunizations protect patients and to find the best way to re-immunize people after cancer treatments.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While the trial's description doesn't specify side effects of the vaccines being tested, common reactions may include soreness at injection site, fever, fatigue or mild rash. Severe allergic reactions are rare but possible.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I finished my chemotherapy for cancer between 3 to 24 months ago.
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I achieved complete remission within 3 months of finishing my therapy, which ended less than a year ago.
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I was diagnosed with cancer before turning 18.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am HIV positive.
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My health status is below 70% on the Karnofsky scale.
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I have had a stem cell transplant from myself or a donor.
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I am currently pregnant or breastfeeding.
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I do not have an ongoing severe infection.
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I am currently taking medication that suppresses my immune system.
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I have received Rituximab treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

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.

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,969 Previous Clinical Trials
597,360 Total Patients Enrolled
Nancy Kernan, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Immunization Schedule (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT00505063 — Phase 2
Childhood Cancer Research Study Groups: A, B, C
Childhood Cancer Clinical Trial 2023: Immunization Schedule Highlights & Side Effects. Trial Name: NCT00505063 — Phase 2
Immunization Schedule (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00505063 — Phase 2
~2 spots leftby Jul 2025
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