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Anti-tumor antibiotic

Actinomycin-D + Vincristine for Childhood Cancer

Phase 4

Waitlist Available

Research Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Due to receive actinomycin-D as a component of cancer treatment

6 months - 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is looking at how well actinomycin-D works in children with cancer, and what the side effects are.

Who is the study for?

This trial is for children aged 6 months to 18 years with cancer who are scheduled to receive actinomycin-D as part of their treatment. They must have a central venous catheter in place and weigh more than 5 kilograms. The child's parent or guardian must give informed consent, and the child should assent if appropriate.Check my eligibility

What is being tested?

The study aims to understand how actinomycin-D, a chemotherapy drug, behaves in the bodies of children with cancer. It will look at how the drug is processed over time (pharmacokinetics) and identify any breakdown products (metabolites) in the plasma.See study design

What are the potential side effects?

While specific side effects aren't listed here, common ones associated with actinomycin-D may include nausea, vomiting, hair loss, mouth sores, diarrhea, and an increased risk of infections due to lowered blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled to receive actinomycin-D for my cancer treatment.

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I am between 6 months and 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Characterization of Plasma Pharmacokinetics to examine the optimal dosing, metabolites and inter-patient variability of actinomycin-D in children with cancer during any sample of chemotherapy.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Lead Sponsor

1,959 Previous Clinical Trials

2,673,616 Total Patients Enrolled

Media Library

Actinomycin-D (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT00491946 — Phase 4

Cancer Clinical Trial 2023: Actinomycin-D Highlights & Side Effects. Trial Name: NCT00491946 — Phase 4

Actinomycin-D (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00491946 — Phase 4

Frequently Asked Questions

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

Are there available slots for participants in this experiment?

"Clinicaltrials.gov states that this specific clinical trial, initially posted on the first of June 2004 and last edited on June 25th 2007, has stopped accepting new participants for now. However, 486 other trials are ongoing and actively recruiting at present."

Answered by AI

What risks do patients face when engaging in this treatment?

"Our team has assessed the safety of this treatment to be a 3, as it is a Phase 4 trial. This signifies that the medication has been approved by regulatory bodies and thus supports its relative security."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Pharmacokinetic Study of Actinomycin-D and Vincristine in Children With Cancer

2004. "A Pharmacokinetic Study of Actinomycin-D and Vincristine in Children With Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00491946.

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