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| Sponsor: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
|---|---|
| Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00491946 |
Purpose
To obtain a preliminary characterization of the plasma PK and metabolites of actinomycin-D in children with cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
Drug: Actinomycin-D Drug: Vincristine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
| Official Title: | A Pharmacokinetic Study of Actinomycin-D and Vincristine in Children With Cancer |
| Estimated Enrollment: | 24 |
| Study Start Date: | June 2004 |
There is a fundamental lack of knowledge regarding optimal dosing of anti-cancer agents for young children with cancer, with resultant increased risk of morbidity, mortality and inferior outcome. Of the anti-cancer agents used frequently in infants and young children, the drug with the least amount of knowledge is actinomycin-D. Actinomycin-D, has been used for the treatment of several childhood cancers since the 1960s. Despite its longstanding and widespread use in pediatric oncology, there is virtually no pharmacokinetic information from which safe and appropriate age-based pediatric dosing can be derived. Actinomycin-D is an integral component of rhabdomyosarcoma and Wilms tumor therapy, and pediatric oncologists will continue to administer the durg despite the gap in knowledge.
Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Pennsylvania | |
| Abramson Research Center | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Donna Sylvester, RN, BSN, BA, CCRC 215-590-3284 | |
| Principal Investigator: Jeffrey Skolnik, MD | |
More Information
| Study ID Numbers: | PPRU 10762 |
| Study First Received: | June 22, 2007 |
| Last Updated: | June 25, 2007 |
| ClinicalTrials.gov Identifier: | NCT00491946 History of Changes |
| Health Authority: | United States: Federal Government |
|
Cancer Actinomycin Vincristine |
|
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Vincristine Enzyme Inhibitors Antimitotic Agents Antibiotics, Antineoplastic |
Pharmacologic Actions Protein Synthesis Inhibitors Anti-Bacterial Agents Dactinomycin Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic Nucleic Acid Synthesis Inhibitors |