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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up conclusion of study
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~conclusion of study
This trial's timeline: 3 weeks for screening, Varies for treatment, and conclusion of study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To prospectively determine the response rate and duration of protective titers following revaccination with routine childhood immunizations in pediatric survivors of childhood cancer.
Secondary outcome measures
To determine whether in vitro parameters of lymphoid reconstitution correlate with response and duration of response.

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
1,933 Previous Clinical Trials
585,547 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you provide an estimate of the cohort size participating in this experiment?

"The clinical trial is currently not accepting participants. It was first posted on July 1st, 2007 and the most recent update was August 9th 2022. Those seeking to join a relevant study can find 24 trials for childhood cancers that are still admitting patients as well as 36 different studies focused on this treatment option actively recruiting volunteers."

Answered by AI

What potential perils might patients incur when utilizing this therapy?

"This treatment has been determined to be moderately safe according to our team at Power, earning it a score of 2; this is due the Phase 2 trial nature meaning there exists safety data partially substantiating its use but no evidence on efficacy."

Answered by AI

Are there any vacancies left for participants in this trial?

"Unfortunately, enrollment for this clinical trial has closed. The study was launched on July 1st 2007 and last updated on August 9th 2022. For those searching for other trials, there are 24 studies related to childhood cancer actively recruiting as well as 36 investigations into this treatment that require participants."

Answered by AI

Is this research accommodating geriatric individuals?

"To be eligible to partake in this clinical trial, participants must be younger than 18 years old. There are 41 studies open for patients within that age group and 23 research opportunities designed for those above 65."

Answered by AI

Would I be qualified to partake in this experimental endeavor?

"For this clinical trial, a cohort of 75 minors aged between 2 and 18 with prior cancer diagnoses is sought. Necessary qualifications include being under 18 years old when the malady was initially diagnosed, having finished chemotherapy within a timeframe of 3 to 24 months before enrollment, documentation confirming complete remission either within three months or around 12 months respectively depending on respective time elapsed since completion of treatment; both genders as well as all ethnic groups are acceptable. Additionally, those participating must comprehend potential risks associated with the research in order to provide valid consent."

Answered by AI

What conditions is this therapy commonly employed to address?

"Traditionally, this treatment is utilized to address mumps. However, it has been proven effective for treating other illnesses such as herpes zoster and tetanus/diphtheria."

Answered by AI
~1 spots leftby Jul 2024