Digoxin for Medulloblastoma

Recruiting at 15 trial locations

Overseen By Jessica Crimella

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Must not be taking: Digoxin, Metabolism interferers

Disqualifiers: Cardiac arrhythmias, Uncontrolled illness, Psychiatric, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 months

23 Participants Needed

Trial Summary

Do I need to stop taking my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot take medications that interfere with digoxin metabolism or any other investigational agents. It's best to discuss your current medications with the study team.

Is digoxin generally safe for humans?

Digoxin has been associated with increased risks of certain cancers, such as breast and uterus cancer, and there is a higher risk of toxicity, especially in women. However, its safety has improved over the years, and studies suggest it may be safe for some cancer patients after adjusting for other factors. ^{1 2 3 4 5}

How is the drug digoxin unique in treating medulloblastoma?

Digoxin is unique in treating medulloblastoma because it is traditionally used for heart conditions but has shown potential antitumor effects by affecting cell growth and survival pathways, such as the NF-κB pathway, which are not typically targeted by standard cancer treatments. ^{6 7 8 9 10}

What is the purpose of this trial?

The purpose of this study is to evaluate the efficacy of digoxin in treating relapsed non-SHH, non-WNT medulloblastoma in pediatric and young adult patients.

Research Team

Jonathan Metts, MD

Principal Investigator

Moffitt Cancer Center

Laura Metrock, MD

Principal Investigator

University of Alabama at Birmingham Children's of Alabama

Eligibility Criteria

This trial is for pediatric and young adult patients aged >12 months and <30 years with relapsed non-SHH, non-WNT medulloblastoma. They must have measurable disease on MRI, stable neurological status, specific cardiac criteria met, normal organ/marrow function, and a performance score of ≥50%. Prior chemotherapy and irradiation are required. Contraception use is necessary for those who can bear children.

Inclusion Criteria

My heart health meets the required standards, and I've seen a cardiologist if needed.

My neurological condition has been stable for at least 7 days.

I have recovered from surgery and been stable for over a week.

Exclusion Criteria

Participants unable to comply with safety monitoring requirements are ineligible

I am not currently taking any cancer treatments or experimental drugs.

I do not have serious or uncontrolled heart rhythm problems.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Digoxin will be administered orally at a standard maintenance dosing. Each cycle will be 28 days.

4 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 months

Treatment Details

Interventions

• Digoxin

Trial Overview The study tests the effectiveness of digoxin in treating specific types of medulloblastoma that have returned after previous treatments. It focuses on patients who do not respond to standard therapies for this brain tumor affecting children and young adults.

Participant Groups

Group I: Digoxin Treatment Experimental Treatment 1 Intervention

Digoxin will be administered orally at a standard maintenance dosing. Each cycle will be 28 days.

Digoxin is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Lanoxin for:

• Atrial fibrillation
• Atrial flutter
• Supraventricular tachycardia
• Congestive heart failure

Approved in United States as Lanoxin for:

• Atrial fibrillation
• Atrial flutter
• Supraventricular tachycardia
• Congestive heart failure

Approved in Canada as Lanoxin for:

• Atrial fibrillation
• Atrial flutter
• Supraventricular tachycardia
• Congestive heart failure

Approved in Japan as Lanoxin for:

• Atrial fibrillation
• Atrial flutter
• Supraventricular tachycardia
• Congestive heart failure

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

National Pediatric Cancer Foundation

Collaborator

Trials

8

Recruited

300+

Findings from Research

In a study of nearly 3 million hospital admissions in The Netherlands from 2001-2004, digoxin intoxication was found in only 0.04% of cases, indicating that such incidents are infrequent among patients receiving digoxin therapy.

Women were found to be 1.4 times more likely to experience digoxin intoxication compared to men, highlighting a gender-specific risk factor in digoxin therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Age- and gender-specific incidence of hospitalisation for digoxin intoxication. Aarnoudse, AL., Dieleman, JP., Stricker, BH.[2018]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Age- and gender-specific incidence of hospitalisation for digoxin intoxication. [2018]

2. Norway pubmed.ncbi.nlm.nih.gov

[Drug safety associated with the change of digitalis drug in Norway]. [2017]

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

Digoxin use and the risk of cancers of the corpus uteri, ovary and cervix. [2020]

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

Digoxin use after diagnosis of colorectal cancer and survival: a population-based cohort study. [2015]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Digoxin use after diagnosis of breast cancer and survival: a population-based cohort study. [2015]

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

Digoxin therapy is not associated with improved survival in epithelial ovarian cancer: A SEER-Medicare database analysis. [2019]

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

Effects of digoxin on cell cycle, apoptosis and NF-κB pathway in Burkitt's lymphoma cells and animal model. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Breast cancer in women using digoxin: tumor characteristics and relapse risk. [2021]

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

Risk of cancer in patients with heart failure who use digoxin: a 10-year follow-up study and cell-based verification. [2018]

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

Digoxin use after diagnosis of prostate cancer and survival: a population-based cohort study. [2018]