Pharmacogenomic Testing for Pediatric Cancer

Overseen By Alicia Patrick

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Prior cancer therapy, Organ transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

130 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of pharmacogenomic testing for pediatric cancer treatment?

Pharmacogenomic testing helps tailor cancer treatment to each child's genetic makeup, improving how well the treatment works and reducing side effects. Research shows that understanding genetic differences can lead to better responses to cancer drugs in children. ^{1 2 3 4 5}

Is pharmacogenomic testing safe for children with cancer?

Pharmacogenomic testing aims to make cancer treatment safer for children by understanding how their genes affect drug reactions. It helps predict and reduce adverse drug reactions, which are common in cancer treatments, making it a promising approach to improve safety. ^{1 6 7 8 9}

How is pharmacogenomic testing different from other treatments for pediatric cancer?

Pharmacogenomic testing is unique because it uses a patient's genetic information to predict how they will respond to certain cancer drugs, allowing for personalized treatment plans that aim to maximize effectiveness and minimize side effects. This approach is different from traditional treatments that do not consider individual genetic differences. ^{1 5 10 11 12}

What is the purpose of this trial?

Pharmacogenomic (PGx) testing involves analyzing variants of genes associated with drug metabolism, transport and medication targets. PGx testing uses an individual's genetic factors, such as single nucleotide polymorphisms (SNPs), to personalize therapy or dose a selection of medications. PGx testing has traditionally been used to test single genes, but there are now platforms allowing a panel of genes to be tested at once. To date there has not been a comprehensive screening of pediatric oncology patients to determine the prevalence of genetic variants that may affect anticancer therapy and supportive care medications. This study would allow us to summarize the frequency of clinically relevant gene-drug interactions and actionable genetic polymorphisms in pediatric oncology patients.

Research Team

Erin Trovillion, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for children with cancer. It's looking to see how often certain genetic variations occur in these young patients, which might affect their response to cancer treatment and supportive care medications.

Inclusion Criteria

Written informed consent and HIPAA authorization for release of personal health information, and assent when applicable, from the participant, parent or legal guardian

I am 26 years old or younger.

I am newly diagnosed with cancer and will start treatment soon, or I need a bone marrow transplant but haven't started the prep treatment.

Exclusion Criteria

I have had or am planning to have a bone marrow transplant for cancer treatment.

I have had an organ or tissue transplant in the past.

I have started treatment for my cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Enrollment and PGx Testing

Participants undergo buccal swab collection for PGx testing at the time of enrollment

Baseline

1 visit (in-person)

Monitoring and Dose Modification

Dose modifications to anticancer therapy and supportive care medications based on PGx results are collected every three months

12 months

Quarterly reviews

Follow-up

Participants are monitored for safety and effectiveness after PGx testing and treatment modifications

3 months

Treatment Details

Interventions

• Pharmacogenomic Testing

Trial Overview The study tests a group of genes at once (pharmacogenomic testing) to find out if there are any genetic factors that could help doctors choose the best medication or dosage for each child based on their unique DNA.

Participant Groups

Group I: Pharmacogenomic (PGx) Testing Experimental Treatment 1 Intervention

Pharmacogenomic Testing is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Pharmacogenomic Testing for:

• Guiding medication selection and dosing based on genetic variations

Approved in Canada as Pharmacogenetic Testing for:

• Informing drug dosing and monitoring for efficacy and safety in children and pregnant women

Approved in European Union as Pharmacogenomic Testing for:

• Personalized medicine through genetic-guided drug therapy

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Atrium Health Levine Cancer Institute

Collaborator

Trials

30

Recruited

4,700+

OneOme, LLC

Industry Sponsor

Trials

3

Recruited

1,100+

References

1. United States pubmed.ncbi.nlm.nih.gov

Pharmacogenomics in cancer treatment defining genetic bases for inter-individual differences in responses to chemotherapy. [2008]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacogenomics in Pediatric Oncology: Review of Gene-Drug Associations for Clinical Use. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Pharmacogenomics in children. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Deliberations about clinical pharmacogenetic testing in pediatric oncology. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Infusion of pharmacogenetics into cancer care. [2013]

6. Cyprus pubmed.ncbi.nlm.nih.gov

Genomic strategies to improve outcome and individualize therapy in cancer: the paradigm of childhood acute lymphoblastic leukemia. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Pharmacogenomics in Pediatric Oncology: Mitigating Adverse Drug Reactions While Preserving Efficacy. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacogenomics and adverse drug reactions in children. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Cancer pharmacogenomics in children: research initiatives and progress to date. [2021]

10. England pubmed.ncbi.nlm.nih.gov

On the pharmacogenetics of non-small cell lung cancer treatment. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

The Role of the Pediatric Pharmacist in Precision Medicine and Clinical Pharmacogenomics for Children. [2020]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Implementing Pharmacogenomics Testing: Single Center Experience at Arkansas Children's Hospital. [2021]